Responsibilities:

1. Implement and manage surveys to collect customer feedback on service satisfaction.
2. Analyze survey data to identify trends and areas for service quality improvement.
3. Collaborate with teams to develop action plans based on survey findings.
4. Monitor key performance indicators (KPIs) related to service quality and report to management.
5. Conduct root cause analysis of service issues and recommend corrective actions.
6. Evaluate and refine survey methodologies for relevance and effectiveness.
7. Provide guidance and support on service quality to internal teams.
8. Stay updated on industry best practices and trends in service quality management.

General Responsibilities:

• Manage feedback and related administrative tasks.
• Represent the organization in events and committees as required

Requirements:

• Degree, minimum 4 years of experience in customer/client servicing or feedback management role. (Experience in healthcare or hospitality sector is a bonus)
• Excellent writing and interpersonal skills.
• Proficient in Microsoft Office.

Interested applicants, please send in your detailed resume in MS Word format.

We regret only short-listed candidate will be notified.

Registration No: R23119349 / Kasie Tay Xiu Yun / EA Licence No: 12C6253

Job Description:

• Extensive knowledge of Nursing acquired through significant experience in a Senior Clinical role.
• Demonstrable experience in quality, safety, and operational leadership with a clear focus on the development and sustainability of services from a quality, outcomes and experience perspective with a clear drive and passion for service change, quality improvement, delivery, and transformation.
• Experience of meeting regulatory compliance standards and the provision, maintenance, and reporting of data to meet compliance.
• Demonstrable experience of the ability to work autonomously, initiating and organizing workloads, delegating appropriately, responding to changing priorities and meeting tight deadlines.
• Demonstrable experience of the ability to make difficult decisions autonomously.
• Demonstrable experience in preparing and delivering Training to enable others to achieve quality and compliance standards across the company.
• Establish new and revise existing quality procedures and tools in support of audit and compliance activities.
• Identify quality process and system improvements and implement timely actions.
• Assist the clinical development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management.
• Collaborate with key stakeholders in the development and implementation of comprehensive internal (systems and procedures) and external (investigator sites and vendors) audit programs and plans.
• Serve as a quality subject matter expert and provide guidance to development personnel performing investigations, root cause analysis, and capas through knowledge of quality concepts and techniques.
• Participate on cross-functional teams as subject matter expert in GCP/GLP/GVP to provide guidance and risk-based options that promote compliance.
• Identify and communicate quality and compliance risks and participate in determination of appropriate planning to resolve and address issues and risks.
• Lead the strategy and activities in support of health authority GCP/GLP/GVP inspections.
• Review clinical study documents and check for consistency and compliance with relevant regulations, standards, and best practices.
• Coordinate projects to successfully meet timelines.

Job Requirement:

• Registered nurse or enrolled nurse background with a passion for patient care.
• Possesses the art of service excellence.
• Experience in management of feedback and service recovery.
• Well-versed in the operations of a service industry.
• Ability to conduct on-the-job training (Service and Clinical).
• Ability to initiate and implement Standard Operating Procedures.
• Ability to display mentorship skills.

To provide clinical and professional leadership, advice and support, maintaining own clinical competence and professional registration. To provide Professional Leadership to the PHN services across Hertfordshire underpinned by the Institute of Health Visiting (iHV), School & Public Health Nurses Association (SAPHNA), and other relevant professional bodies/national networks; working through the School Nursing Clinical Leads when required. To contribute to the strategic goals of the Public Health Nursing (PHN) and Family Centre Services (FCS), to achieve successful delivery of the service model and contract 2018-2024 (plus 2 years) through the delivery of a comprehensive education programme for the PHN service. To contribute to the achievement of the strategic aims and objectives of Hertfordshire Community NHS Trust. To work effectively with commissioning groups and other stakeholders, ensuring effective communication and partnership working in relation to Quality and Quality Improvement work streams. To support the Assistant Directors and Pathway/Service Leads (Named Services and QI) in the delivery of high-quality services, ensuring an integrated approach, focused on meeting the needs of adults/children and their family/carers. To ensure services are delivered in a highly professional and clinically safe manner, in conjunction with the business support team and in accordance with local and national policies and procedures. To take responsibility for supporting improvement projects across named services, ensuring teams are engaged in change with QI process adhered to. To be responsible for ensuring Quality outcome measures are developed and implemented within areas of service responsibility. To work collaboratively with the Assistant Directors and Pathway/Service Leads in the preparation of the Business Units Delivery Plan, CQUINs and Quality Priorities. Prepare and deliver named service peer reviews as agreed, reporting on the performance of services within area of responsibility.

Clinical Quality and Compliance Officer Service Integrated Communities | Queanbeyan , Stirling, Calwell, WarrigalHughes Great Culture & On-boarding Process Location: Canberra/ Queanbeyan Grow your career to the next level NFP salary packaging benefits – pay less tax, bank more! (up to $18,550k pa tax free) Hourly Rate: Negotiable on experience Packaging Benefits Super The role: In joining the Operational Quality and Compliance team, you will use your clinical skills to deliver the organisational quality and compliance program to meet the Aged Care Quality Standards. This includes conducting audits and monitoring compliance, and supporting best clinical practice across the various Warrigal locations including the Illawarra, Southern Highlands, Queanbeyan and the ACT. Some travel to these locations may be required. To be successful you will need:  Registered Nurse with current Registration under the Australian Health Practitioner Regulation Agency Proven substantial experience working in the Aged Care industry in a quality or similar role Demonstrated clinical auditing experience Strong…

Click here to view more detail / apply for Clinical Quality and Compliance Officer

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be tasked with the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. They will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Primary Duties:

Operational Quality Management:

• Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. 

• Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT. 

• Collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.

• Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).

• Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.

• In partnership with the CQOL, the CQOM will develop skill sets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).

• Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.

• In collaboration with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.

Inspection Preparation and Management:

• Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.

• Lead and support GCP inspections, worldwide.  The CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.

• Team up with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.

• Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).

• Contribute to the development and/ or revision of our Company policies, SOPs and training materials.

• Develop the strategy for management/support for GCP inspections of our Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.

• Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.

• In partnership with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.

• Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.

• Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.

• Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.

CAPA Management Support:

• Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner.  Track all inspection CAPA and regulatory commitments and checks evidence of completion.

• Ensure repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.

• Provide guidance and support for CCQMs regarding inspections at a country level sites that require a company headquarters input.

Other activities:

• Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.

• Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.

• Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.

Education: 

• Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.

Experience:

• Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.

• Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.

• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.

• Experience with delivering effective CAPA management solutions.

• Experience with risk management tools and processes within the clinical quality framework.

Skills: 

• Superior oral and written communication skills in an international environment.

• Ability to manage and develop others, including formal performance management when required.

• Excellent project management and organizational skills.

• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.

• Lead cross-functional teams of business professionals within and outside our Research Division.

• Act urgently for worldwide health authority inspection matters.

• Analyze, interpret and solve complex problems.

• Think strategically and objectively and with creativity and innovation.

• Effectively interact with all levels of specialists & management and exert influence to achieve results.

• Identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned. 

#EligibleforERP

MRLGCTO

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

Click here to request this role’s pay range.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$135,500.00 - $213,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Position Summary: Responsible for designated quality assurance and quality control activities and to ensure compliance to established standard operating procedures and regulatory guidelines. The associate is to ensure that supplies, facility and processes are maintained to cGMP standards.

Essential Duties and Responsibility:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures, including local and international regulations applicable to clinical trials supply chain activities
• Maintain a good understanding of local and international regulations, and keeping abreast with regulatory changes and developments
• Provide consultative guidance on quality related matters to clients and internal associates
• Document Control Management
• Conducts internal/supplier audits according to SOP requirement and assist in regulatory, supplier and client audits
• Perform pre and post review and approval of production batch records
• Perform pre and post review and approval of label printing records
• In-Process Inspection Responsibilities for production and label printing jobs
• Management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions
• Responsible for quality compliance of controlled temperature shipments
• Approval of components and material specifications
• Responsible for the release of client/Fisher supplied materials
• Prepare new and update existing job related Standard Operating Procedures (SOPs)
• Assist in the QA/GMP training of employees across the company
• Participate in department systems development initiatives to improve regulatory and quality efficiency and compliance
• Perform ad-hoc duties as requested by line management

Minimum Qualifications

Degree in any discipline

At least 5 years of relevant experience

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Looking for candidates with:

- Bachelors level clinician (RN) or Masters level clinician (LCSW, LPC, LMHC, MFT) or a provisional license.
- 3+ years of clinical experience
- Will substitute 5 or more years of clinical experience along with an Associates degree and RN licensure in place of the Bachelors degree and RN licensure.
- Experience working with total quality improvement or a behavioral healthcare background in treatment modalities, psychopharmacology, federal/state regulatory guidelines, performance measurement.
- Ability to work independently with minimal supervision.
- Project management skills and demonstrated experience.

- Candidates must live within a reasonable commute to the Boise, Meridian, Eagle, Mountain Home, Caldwell and Nampa areas. This is a hybrid role.

Conducts reviews of clinical interactions and clinical documentation including reviews of case management records and provider treatment records. Collects data following established procedures and analyzes findings for purposes of continuous quality improvement and for internal and external reporting. Interacts with multiple stakeholders internally and externally. Provides clinical reviews of Quality of Care (QOC) and Critical/Adverse incidents related to clinical services.

• Audits and reviews case manager and provider clinical documentation and telephone interactions against regulations, accreditation standards and contract requirements. 
• Reviews provider treatment records against clinical and procedural established standards.
• Conducts ongoing activities which monitor established quality of care standards in the participating provider network and for care managers.
• Conducts reviews of Quality of Care and Critical/Adverse Incidents.
• Evaluates level of patient safety risk and need for follow-up actions per policies.
• Collects, analyzes and prepares clinical record information for projects related to assessing the efficiency, effectiveness and quality of the delivery of managed care services. 
• Prepares monthly performance reports with assistance from Reporting and Analytics unit.  Presents findings at provider and customer meetings as needed.
• Assists in the planning and implementation of activities to improve delivery of services and quality of care including the development and coordination of in-service education programs for providers and care managers.
• Responsible for auditing as well as validating internal audit results and/or corrective action plans.

Other Job Requirements

Responsibilities

Bachelors level clinician (RN) or Masters level clinician (LCSW, LPC, LMHC, MFT) required.
3+ years of clinical experience required.
Will substitute 5 or more years of clinical experience along with an Associates degree and RN licensure in place of the Bachelors degree and RN licensure.
Experience working with total quality improvement or a behavioral healthcare background in treatment modalities, psychopharmacology, federal/state regulatory guidelines, performance measurement.
Ability to work independently with minimal supervision.
Project management skills and demonstrated experience.

General Job Information

Title

Quality Clinical Reviewer

Grade

25

Work Experience - Required

Clinical

Work Experience - Preferred

Quality

Education - Required

A Combination of Education and Work Experience May Be Considered. - Nursing, Bachelor's - Nursing, Master's - Behavioral Health

Education - Preferred

PsyD - Clinical Psychology

License and Certifications - Required

LCSW - Licensed Clinical Social Worker - Care Mgmt, LMHC - Licensed Mental Health Counselor - Care Mgmt, LPC - Licensed Professional Counselor - Care Mgmt, MFT - Marriage and Family Therapist - Care Mgmt, PSY - Psychologist - Care Mgmt, RN - Registered Nurse, State and/or Compact State Licensure - Care Mgmt

License and Certifications - Preferred

Salary Range

Salary Minimum:

$64,285

Salary Maximum:

$102,855

This information reflects the anticipated base salary range for this position based on current national data. Minimums and maximums may vary based on location. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors permitted by law.

This position may be eligible for short-term incentives as well as a comprehensive benefits package. Magellan offers a broad range of health, life, voluntary and other benefits and perks that enhance your physical, mental, emotional and financial wellbeing.

Magellan Health, Inc. is proud to be an Equal Opportunity Employer and a Tobacco-free workplace. EOE/M/F/Vet/Disabled.
Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their position; and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures.

PRIMARY DETAIL

Appointment type: Full time, continuing
Salary Package: From $115,030 to $127,995 p.a. (HEW 8), plus 17% employers superannuation and annual leave loading
Flexible working arrangements e.g. a 9 day fortnight are available
Macquarie University (Wallumattagal Campus, North Ryde)

THE ROLE

The Clinical Trials Quality Manager is a leadership role providing clinical trial regulation expertise to ensure a continued focus on quality and compliance. The role is responsible for our quality management system, and coordination and tracking of staff training. It has 2 direct reports and 6 indirect reports:

• Quality Management System: Design, implement and maintain a comprehensive Quality Management System (QMS) program to ensure consistency of practice to the highest quality standards across clinical trials, and to ensure compliance with ICH GCP, regulatory requirements, Ethics committees and Macquarie University (MQ) policies and procedures.

• Process Improvement: Drive system and process reviews and improvement initiatives to optimise trial quality and compliance.

• Audit and Inspection Management: Oversee preparation for audits and inspections, and responses to audits and inspections to ensure appropriate follow up of any findings including sharing learning across relevant staff in the CTU.

• Staff training: Oversee comprehensive training needs assessments and implementation and tracking of training programs meeting personal development requirements, as well as tracking and overseeing routine repeat trainings (ICH-GCP, Basic Life Support and safe laboratory sample handling and shipping etc).

• Workforce development: Oversee the clinical trial trainee program ensuring a pipeline of trained staff for entry level positions in the CTU.

• Leadership: contribute to strategic planning, team culture and CTU leadership and drive a continuous improvement culture and quality mindset in the CTU.

About You 

You will have extensive experience working on sponsored clinical trials ideally in a quality role. You will have experience managing, training and mentoring. You will have strong analytical skills with the ability to solve problems. You will have the ability to lead and deliver on projects involving risk management and process improvement in a clinical trial setting.  You will be passionate about working in clinical trials. 

About Us 

The Clinical Trials Unit (CTU) is part of the Faculty of Medicine, Health and Human Sciences (FMHHS) at Macquarie University. FMHHS also has the Macquarie Medical School, the Macquarie University Private Hospital, and runs patient clinics, labs, imaging and a pharmacy all on campus in close proximity to support clinical trials, and support providing patients with access to state of the art treatments. The CTU undertakes sponsored and investigator initiated Phase I to IV trials across multiple therapeutic areas with multiple Principal Investigators. Our current team of over 60 staff (managing over 120 trials) are a close knit inclusive team with a supportive culture that values team work and innovation.

Macquarie is a university engaged with the real and often complex problems and opportunities that define our lives. Since our foundation 54 years ago, we have aspired to be a different type of university. Over the years, we’ve grown to become the centre of a vibrant local and global community. Connect with us today.

To apply 

To be considered for this opportunity, please apply online and attach your resume and a separate cover letter that demonstrates how you meet to the selection criteria below: 

• Extensive clinical trial experience ideally including working on sponsored trials at a trial site

• Extensive knowledge of clinical trials processes and Australian regulatory framework and international regulations and guidelines related to Phase I to IV clinical trials

• Demonstrated experience leading and delivering on projects involved in risk management and process improvement in a clinical trial setting

• Demonstrated experience managing, training and mentoring

• Passionate about working in clinical trials

Note: This position requires a criminal record check.

Eligibility for this position requires full work rights and Australian Citizenship or Permanent Residency.

Role Specific Enquiries: Nicola Chapman at Nicola.chapman@mq.edu.au

General Enquiries: Jasmine Xia at jasmine.xia@mq.edu.au  

Applications Close: Sunday, 31 March 2023 at 11:55pm AEST 

Note: This position requires you to comply with occupational screening, assessment and vaccinations in line with Macquarie University health requirements. You will also have to satisfy Macquarie University that you meet all background checks (including criminal record and working with children and qualification checks).

If you're already part of the Macquarie Group (MQ University, U@MQ, MQ Health, MGSM), you'll need to apply through your employee Workday account. To apply for this job: Login to Workday and go to the Careers App > Find Jobs.

Applications Close:

31/03/2024 11:59 PM

Diversity and Inclusion

A Vacancy at West Hertfordshire Teaching Hospitals NHS Trust.


Lead Our Quality Assurance Team at WHTH NHS Trust.

Do you thrive on accuracy and have a passion for ensuring the best possible healthcare? Are you a leader who can inspire a team and drive continuous improvement?

If so, then we want you to join our dynamic clinical coding team at West Hertfordshire Teaching Hospitals NHS Trust as our Clinical Coding Quality Assurance Lead.

This is a full-time position covering 37.5 hours a week.We welcome great talent from all backgrounds and provide a flexible work environment and hybrid working options focused on positivity and progress.

Submit your application today and join our friendly and supportive team now.

In this pivotal role, you'll play a leading role in:
• Shaping the future of clinical coding at WHTH: You'll develop and implement a robust quality assurance strategy, ensuring the accuracy and completeness of coded data that underpins vital healthcare funding and national benchmarking.
• Empowering your team: Provide mentorship and training to our team of clinical coders, fostering a culture of excellence and continuous learning.
• Becoming a coding authority: Conduct regular audits and trainings in line with the latest guidelines, identifying areas for improvement and implementing effective solutions.
• Championing collaboration: Work closely with clinical and finance colleagues to ensure our coding practices are efficient and support high-quality patient care.

There has never been a more exciting time to join West Hertfordshire Teaching Hospitals NHS Trust! Major redevelopment works are planned as part of the New Hospital Programme. These will be most dramatic at Watford General Hospital where up to 90% of buildings will be new.

The trust has recently gained ‘teaching hospital’ status which reflects the dedicated work of many teams and individuals who have set the standard for delivering high quality training, learning and education at all levels of the workforce.

We are a flexible working employer.

At West Herts we recognise the importance of a good work life balance and the ability to work flexibly. We are delighted to offer a variety of flexible working options for all staff. Please check out our web page for more information.

https://www.westhertshospitals.nhs.uk/flexibleworking/

We encourage and welcome people with disabilities. If you need help, please ask.

We reserve the right to close this advert early due to the volume of applicants. Please apply as soon as possible to avoid disappointment.

If you do not hear back within 3 weeks of your application, please assume you have been unsuccessful on this occasion.

We're looking for someone who:
• is a highly motivated and experienced NHS Digital Approved Auditor with a minimum of 3 years' experience in a lead coding role.
• is an experienced Approved Coding Trainer.
• thrives in a fast-paced environment and enjoys problem-solving.
• has excellent communication and interpersonal skills, able to build strong relationships and inspire a team.
• is a natural leader with a commitment to continuous learning and development.




This advert closes on Wednesday 27 Mar 2024

Job Description

It is critical that, for all clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained.

The Country Clinical Quality Manager (CCQM) has a significant impact in achieving those objectives.

Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the respective country/cluster.

The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

RESPONSIBILITIES:

Regulations & Processes:

• Local expert for local regulations (incl. impact assessment of new/updated local regulations on local processes).
• In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions.
• Local expert for any quality-related local processes.
• Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).
• Leads continuous quality improvements activities at the country level as agreed with Country/Cluster and supports or co-leads continuous improvements activities at the global/regional level.

Training:

• Local training point of contact and the liaison between local country operations and Learning & Development (L&D).
• In close cooperation with local country operations management, identifies / coordinates local training needs.
• Supports local training (as needed).

Quality Control (QC) Activities:

• In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan, the Quality Control Visits as well as any other QC Checks.
• In mutual agreement with local country operations management and the RCQM, performs QC activities and conducts ad hoc site visits upon request.
• On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).

Audits & Inspections:

• Primary local point of contact for Quality Assurance and Regulatory Agencies.
• Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.
• In cooperation with local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
• On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required).

Quality / Compliance / Privacy Issue Escalation:

• Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
• Escalates significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
• Serves as local POC or supports local POC in case of escalations/reporting of Privacy Incidents, if applicable.

QUALIFICATIONS, SKILLS & EXPERIENCE:

• Bachelor's Degree or equivalent in relevant health care area.    
• A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.
• Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.  
• Demonstrated experience in leading cross-functional teams.
• Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.
• Ideally, experience in managing audits and inspections.
• Ideally, experience in coordinating and delivering training sessions.
• Required: Romanian native, English Business proficiency
• Advantage: Bulgarian Business proficiency
• Superior oral and written communication and leadership skills in an international environment.  
• Excellent project management, organizational and prioritization skills.  
• Excellent teamwork skills, including conflict resolution expertise and discretion.
• Ability to analyze, interpret, and solve complex problems.  
• Ability to think strategically, objectively and with creativity and innovation.  
• Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.   
• Driving license: Valid B category

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. Utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.

This position is responsible for the execution of the global Quality Assurance audit activities on assigned studies, products, vendors and Country Offices. This role is accountable for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures, policies, and all applicable worldwide regulations and guidelines.

Primary activities include, but are not limited to:

• Prepares and conducts Quality Assurance (QA) audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g., Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable;
• Activities may include Good Clinical Practice (GCP) and Pharmacovigilance (PV) routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third-party collaborations and due diligence activities; 
• Will represent QA as a single point of contact and provides QA guidance for studies;
• Serves as a member of the project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls;
• Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise;
• Proactively identifies, analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies;
• In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate;
• Actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements);
• Analyze and leverage quality indicators and data to identify potential trends and risks and perform root cause analyses to enable principles of knowledge-based auditing;
• Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions. Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the Quality Assurandce Lead and Therapeutic Area Head;
• Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies;
• Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally;
• Provide inspection management support as appropriate;
• Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards;
• Promotes standardization of auditing approach within QA;
• Routinely suggests new audit techniques/aids in areas of technical expertise;
• Design and actively participate in special assignments on various project teams and work streams as determined by QA management.

Main requirements:

• Bachelor's degree or higher (or equivalent qualifications) in pharmacy or a life-science subject;
• Broad and in-depth knowledge of the drug development process, Good Clinical Practice guidelines, and applicable regulations is essential;
• Experience as a clinical quality professional is required;
• Experience as a clinical quality auditor will be considered a plus;
• Business Acumen and Attention to Detail.
• Logic and analytical skills using rigorous logic and methods to solve difficult problems with effective solutions;
• Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats;
• Creative Thinking engaging new ideas or ways of doing things and influences creative thinking;

  

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

n/a

Job Description

It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives.  

Under the guidance of the Regional Director, Clinical Quality Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead establishes and/or   local clinical Quality Management System (CCQMs) aiming to achieve the organizational strategic goals and business objectives.  

The role is responsible for oversight of all CQM activities in a country/cluster of countries, or to collaboratively oversee all CQM activities in a country with multiple CRDs aligned along TA and/or functional lines.    This includes line management of Country Clinical Quality Managers (CCQMs) and Associate Country Clinical Quality Managers (ACCQMs) as well as talent development in collaboration with RCQM.  

The role requires the ability to properly oversee and/or lead local quality operations to implement local/regional/global processes/procedures, to identify opportunities for process improvement, and to support continuous improvement initiatives. Advanced skills in strategic thinking, project management, ability to lead during ambiguity, analysis and risk-based decision-making and stakeholder management are required for this role.  

In addition, the Sr CCQM Lead supports audits, inspections, quality issue management as well as Quality Control and local training activities, as needed.   

Qualifications:  

• Bachelor's Degree.

• Advanced degree (e.g., Master’s Degree, PhD) preferred.  

Experience:  

• A minimum of 10 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred. 

• Minimum of 2 years´ experience in a functional and/or line management position.

• Deep knowledge and understanding of Clinical Trial processes, GCP and applicable clinical research-related regulations.

• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.  

• Demonstrated experience in leading cross-functional teams.

• Experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.  

• Demonstrated, stakeholder management and data analytics.  

• Demonstrated experience in people management  

• Ideally, experience in managing audits and inspections.

• Ideally, experience in coordinating and delivering training sessions.  

Skills:  

• Superior oral and written communication and leadership skills in an international environment.  

• Excellent project management, organizational, risk-based evaluation, and prioritization skills.  

• Superior leadership skills to effectively lead managers including talent development skills.  Excellent teamwork skills, including conflict resolution expertise and discretion.  

• Ability to analyze, interpret, and solve complex problems.  

• Ability to think strategically, objectively and with creativity and innovation.  

• Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

• The seniority level requires the capability and leadership to work with managers and executive teams to make critical decisions or offer solutions to complex situations that may potentially affect a wide area or our company/ processes

Regulations & Processes:  

• Expert for ICH-GCP and deep knowledge and understanding of Clinical Trial Processes and other regulations. In close collaboration with local country operations management and CCQMs/A CCQMs, manages the local network of owners / Subject Matter Experts (SMEs) for global/regional/local processes to ensure a proper implementation of global/regional/local processes and the regular update of local Standard Operating Procedures (SOPs) / Business Procedures (BPs)

• Expert for any quality-related processes.

• Identifies process gaps / opportunities for process improvement with CCQMs and properly escalates to RCQM and/or Global Process Owners (if necessary).

• Leads, or oversees CCQMs/A CCQMs to lead, continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvements activities at the global/regional level.  

Training:  

• Local training point of contact and the liaison between local country operations and our Research Division Learning & Development (L&D), if applicable  

• In close cooperation with local country operations management and local CQM team, identifies / coordinates local training needs.  

• Supports local trainings (as needed).  

Quality Control (QC) Activities:  

• In conjunction with the local country operations management & local CQM team, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.

• In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request. 

• On a regular basis and in collaboration with local country operations & local CQM team, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).

• In agreement with the RCQM, presents trend analysis on QC data to the GCTO Leadership Team of the country/ies.  

• Ensures timely completion of Clinical Supplies GCP Investigations.  Audits &

Inspections:  

• Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.

• In cooperation with local CCQM, local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates/approves the responses to audit/inspection reports.

• On a regular basis and in collaboration with local country operations & local CQM team, identifies local trends, performs root-cause-analysis (if necessary and develops local action plan (incl. sharing of results and training of local country operations, if required).  Quality / Compliance / Privacy Issue

Escalation:  

• Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.

• Escalates significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.

• Serves as local POC or supports local POC in case of escalations/reporting of Privacy Incidents, if applicable.

• Sr CCQM Led is responsible to manage, or oversee the delegated direct report(s) to manage if applicable, the following: o Clinical Supplies GCP Investigations o Local Supplier Qualification and verification o Local Supplier Oversight o Our Research Division Country Compliance Steward o Our Research Division Country Privacy Steward    Global / Regional Key Initiatives / Projects

• Supports global/regional key initiatives/projects upon request of the RCQM. 

#EligibleforERP

MRLGCTO

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

 

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$164,800.00 - $259,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Are you a current Elekta employee?  

Please click here to apply through our internal career site Find Jobs - Elekta.

Want to join a team with a mission to improve and save lives?  

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

We don’t just build technology. We build hope.

Here at Elekta, you will make a difference. Our growing Clinical Solutions Verification Engineering team has opportunities in development and testing of new and existing products. Our product teams thrive in a scaled, agile environment. Architects, product owners, designers and developers collaborate closely to rethink and reimagine, and we need your expertise to create software that is simple, elegant, and easy to use. We want to make sure that physicians spend their time fighting cancer, not software.  

What you’ll do at Elekta

As a Solution Verification Test Engineer at Elekta you will work within clinical settings to create and run solution-level test procedures and deliver verification demonstrating that the Elekta Medical Linear Accelerator solution works as a cohesive unit and fulfils its intended purpose.

You will maintain expert domain knowledge in one or more chosen areas as well as develop and maintain broad knowledge of products across our solutions. To succeed in this role, you need to demonstrate an eagerness to adapt and learn when new products are added to the Elekta Medical Linear Accelerator solution. The more you know and learn about the products the more can you contribute to the Solution Verification activities, Project Level Contributions and Process Compliance and Improvement.

In this role, you will assist the Solution Verification Team Lead in the identification of regression test sets. It is you who should ensure that changes made to the systems under test are reverted to a known good baseline and work with the Test Facilities team to ensure the necessary equipment and system configuration are in place for planned verification activities.

The right stuff
The Solution Verification Test Engineer responsibilities include (but are not limited to):

• Review solution-level requirements for testability as part of developing test procedures.

• Create Test Procedures to cover allocated requirements.

• Review allocated test procedures for adequacy of test coverage.

• Run approved test procedures against the solution recording results accurately and with an appropriate level of detail.

• Take ownership/responsibility to drive blockers and issues found to satisfactory resolution through own action, or collaboration with others as appropriate.

• Create problem reports, ensuring clear steps to reproduce are captured for issues found.

• Complete any required retesting of raised problem reports and previously failed test runs.

• Draw on own product knowledge and domain experience in the creation of Solution Verification Plans as required.

• Ensure the team Lead and Department manager are made aware of identified issues or risks.

• Take responsibility for own conformance with solution-level verification processes and procedures.

• Provide feedback to the Solution Verification Department Manager on Solution Verification processes and procedures and propose possible improvements.

What you bring

We’re looking for team players, forward thinkers, caring and daring colleagues who want to innovate and keep pioneering cancer care together with us.

• Clinical experience (Radiotherapist), associated degree/qualification.

• Physics experience (Medical physicist), associated degree/qualification

• Planning experience (Dosimetrist), associated degree/qualification

• 3rd party device experience (Catalyst, VisionRT, ABC etc)

• Minimum 5 years real-world experience

• Testing experience (ISTQB qualification)

• Thorough understanding of the intended use of new products, coupled with the ability to translate this understanding of the requirements into structured and comprehensive test plans and procedures.

• Must be self-motivated and able to interact well with others.

• Strong analytical, problem solving, and presentation skills.

• Excellent written, verbal communication and IT skills.

• Awareness of SAFe Agile framework is an advantage.

What You’ll Get

In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. In addition to this, Elekta offers a range of benefits.

• Flexible working hours (this role is a hybrid and you must be able to commute to Crawley

• Group Income Protection

• Private Medical Insurance

• Pension

• Dependants’ Pension

• MyElektaBenefits

• Introduction Bonus Scheme Policy

• Holiday Purchase

• Cycle to work scheme

• Flexible working hours

• Overtime Policy

• Childcare Vouchers

• Private Medical Insurance

• Life Assurance

• Long Service Awards

Hiring process

We are looking forward to hearing from you! Apply by submitting your application and résumé in English, via the “Apply” button. Please note that we do not accept applications by e-mail.

Your Elekta contact

For questions, please contact the responsible Global TA Partner, Sarah Elmasry at sarah.elmasry@elekta.com. We do not accept applications through e-mail.

We are an equal opportunity employer

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.

Job Category:

Clinical Support

Work Shift/Schedule:

8 Hr Morning - Afternoon

Northeast Georgia Health System is rooted in a foundation of improving the health of our communities.

About the Role:

Job Summary

The Clinical Quality Analyst is responsible for pursuing and implementing innovative approaches to data collection, analysis, interpretation and presentation in order to support planning and decision-making related to clinical quality improvement and assists in managing data as a strategic resource. This position requires technical expertise with EPIC and Business Intelligence reporting capabilities, clarity reports and workbench reporting to successfully mine and validate data. The Clinical Quality Analyst will take the lead in working with the Quality team, clinical management, and clinicians to develop analyses that address issues of utilization, cost, quality, outcomes and program development in their area(s). The Analyst will assist in developing, generating and maintaining benchmarks, trend and variance reports, as well as other requested output from the organization on both an ad hoc and ongoing basis. This position defines, organizes, and presents data against established benchmarks and operational workflows while identifying and recommending workflow changes as appropriate and must be able to ensure reliability and integrity of methods, modeling processes, and output products at all levels of complexity. The Analyst must demonstrate a creative ability to develop and lead data presentations as determined by need and analysis, and to assist with other types of learning sessions and committee or other team meetings designed to support optimum patient outcomes and financial initiatives in the ambulatory care setting. The Analyst must be able to work with clinic staff in recognizing and documenting best practice workflows for optimal data outcomes. 

Minimum Job Qualifications

• Licensure or other certifications: Clinical certification or license required (i.e., Medical Assistant, LPN, or coding). ASQ CQIA (Certified Quality Improvement Associate) required or obtained with six (6) months of hire.

• Educational Requirements: "Other"

• Minimum Experience: Minimum of three (3) + years of relevant experience in healthcare, data analysis/analytics and/or project management roles. At least two (2) years' experience with Epic electronic medical record is required. 

• Other: Bachelor's Degree or certification in Clinical Informatics, Health Administration, Business Administration or other related data curriculum required or enrollment verification is required upon hire if the candidate is pursuing a Bachelors Degree.

Preferred Job Qualifications

• Preferred Licensure or other certifications: Project Management

• Preferred Educational Requirements:

• Preferred Experience:

• Other:

Job Specific and Unique Knowledge, Skills and Abilities

• Excellent self-management and organizational skills and ability to work independently and as part of a team

• High degree of professionalism and capacity to manage relationships with a wide variety of individuals in differing roles, e.g., senior management, Board members, physicians, employers, government, consumers, media

• Excellent written and oral communication skills with high degree of competency in manipulating and presenting large data

• Ability to be flexible, prioritize and manage multiple tasks concurrently with minimal supervision

• Strong analytical and problem-solving skills with excellent attention to detail

• Proficient with Business Intelligence, clarity, and workbench reporting, and other data reporting and presentation software (e.g., Excel)

• Competent in designing related databases, spreadsheets, or outputs

• Skilled at generating standard or custom reports summarizing clinical, financial, or operational data for review by executives, managers, physicians and other stakeholders

• Able to match BI and other reporting formats to the customer's needs for decision support. Conducts or coordinates appropriate testing and/or data validation methods to ensure that data is consistent with defined needs

• Excellent analytical, problem solving, time management and interpersonal skills

Essential Tasks and Responsibilities

• Able to develop business intelligence data that provides relevant information and insights for customers in a user-friendly format.

• Collaborates with other analysts and IT members to ensure understanding of EPIC functionality is current, especially related to data mapping.

• Conducts and/or coordinates testing of data to ensure data and reports are consistent with customer defined needs.

• Responsible for data mining, collection and extraction and developing methods for database design and validation reports.

• Documents specifications for data collection and extraction for continuity across reporting formats and timeframes.

• Utilize computer software (i.e., Microsoft Excel, Word, PowerPoint, etc.) for creating reports, calculations and audits, and managing databases.

• Communicate findings effectively using various methods (verbally, PowerPoint, Excel, Word, etc.) to a wide variety of customer stakeholders (clinicians, providers, senior leaders, providers, IT partners, Quality Council, other physician decision groups, and other members of the leadership team) to include development and educational support of operational workflows and standard work.

• Responsible for responding to requests for ad hoc analyses, building standardized reports and tools, as well as education physician and staff users on findings, outcomes and standard work development.

• Comply with all measures for patient confidentiality and security of electronic information.

• Assist in supplying and applying data analytics.

• Assist in the presentation of data related to clinical operations to accomplish product line profitability analysis, population health quality goals, and to support programs such as pay for performance and shared savings arrangements, chronic disease management program, and quality improvement programs and projects.

• Refine existing queries, algorithms, and/or standard work to support practice goals.

• Develop new queries using various query tools to extract data from existing databases and to integrate that data with data from other sources.

• Documents query methodology to allow for reporting continuity for standard reports and for better understanding and modification of reports.

• Maintains work plan of rerunning queries that may be needed daily, weekly, monthly, quarterly or annually (e.g., opioid reports for Quality Council, data updates for A3s).

• Leads efforts focused on optimization and data quality. Duties may include audits of data or systems to look for defects and incomplete data and works with staff to develop a path/plan for remediation.

• Audits validity of data by running other reports, checking against trends, standard work, approved Provider incentive metrics and other specified mechanisms.

• Works with practice site managers and/or administrators, care management staff, and others to maximize the quality of data collection as needed.

• Participates in meetings with staff to improve strategic use of data as requested.

• Reads materials and stays current related to the definition of queries, such as definitions for numerators or denominators, and notes defects in data.

• Functions as Provider and population health support and represents the Department on the Epic Ambulatory Advisory Committee.

• Generates reports and analysis to find opportunities to help providers deliver high quality care.

• Makes presentations to internal & external stakeholders about health care cost and utilization. Success will depend on having the ability to present the data in a compelling way that highlights the opportunities at hand - whether in making comparisons to benchmarks, pointing out anomalies, displaying trends over time, or using other creative analytical tools.

• Other duties as assigned.

Physical Demands

• Weight Lifted: Up to 50 lbs, Occasionally 0-30% of time

• Weight Carried: Up to 50 lbs, Occasionally 0-30% of time

• Vision: Moderate, Frequently 31-65% of time

• Kneeling/Stooping/Bending: Occasionally 0-30%

• Standing/Walking: Occasionally 0-30%

• Pushing/Pulling: Occasionally 0-30%

• Intensity of Work: Frequently 31-65%

• Job Requires: Reading, Writing, Reasoning, Talking, Keyboarding, Driving

Working at NGHS means being part of something special: a team invested in you as a person, an employee, and in helping you reach your goals. 

NGHS: Opportunities start here.

Northeast Georgia Health System is an Equal Opportunity Employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, protected veteran status, genetic information, or any other legally protected classification or status.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Associate Director Clinical QA, you will be trusted to provide input and assist in establishing the vision and strategic direction for Clinical R&D activities in the R&D, QA, GCP, GLP and Medical Safety Operations Groups at our Main Campus in Fort Worth, TX.

POSITION PURPOSE

• Provides input and assist in establishing the vision and strategic direction for Clinical R&D activities as part of the R&D QA GCP, GLP and Medical Safety Operations Group.
• Provides Clinical QA oversight to ensure that global Clinical Operations activities conducted by Alcon for its medical devices and pharmaceutical products are in compliance with applicable regulations, guidelines and/ or quality standards.
• Manages the Good Clinical Practice (GCP) audit program across all Alcon franchises to assure clinical related activities are conducted according to Alcon and quality standards and applicable regulations with high degree independence.  

In this role, a typical day will include:

• Provides leadership and sound business ethics in the interpretation and implementation of global GxP compliance programs, computer system and/or software validation and related services and compliance training while ensuring Clinical QA independent assessments.
• Supports clinical research and development activities for all Alcon franchises and Technology Platforms to maximize standardization and compliance.
• Advises senior management of the need for corrective and preventive actions with a key advisory role in the development of action plans and monitoring of effectiveness of action plans as a result of internal and/or external Regulatory audits.
• Ensures senior management awareness of compliance issues impacting regulatory acceptability, by appropriately escalating as per quality risk management.
• Provides support to relevant functions on proper identification and escalation of quality related issues.
• Trends, interprets and presents compliance data and metrics according to worldwide legal and regulatory requirements and Alcon standards.
• Drives/facilitates projects in collaboration with stakeholders to evaluate and or implement quality/compliance improvement initiatives.
• Leads or support cross-functional teams to evaluate impact of process changes to systems and related processes, to research best practices, determine solutions and manage change.
• Develops unique approaches to promote and instill a culture of quality and compliance.
• Provides coaching, and aid in the development of RDQA Clinical staff and business partners.
• Provides consultation and education including, but not limited to interpretation of global regulations and guidelines such as GCP, US FDA EU MDR, ISO Standards, etc.
• Authors or reviews & approves documentation including but not limited to audit schedule, plans and reports, documents associated with regulatory submissions, notes to file, study protocols, document templates, plans and reports, and clinical evaluation documents.
• Leads and supports the investigation of deviations and other quality issues detected from any source e.g., monitoring and data management, trends, signals, etc. 
• Provides guidance, review, and approval of associated deviations (NCI, CAPAs and Actions) and evaluates effectiveness.
• Provides R&D QA support to Supplier Evaluation Teams, and function as Clinical SME for service providers.
• Leads audit & inspection preparation, conduct and remediation as needed, for both national and local inspections (e.g., FDA, EMA, MHRA, TUV etc.).
• Contributes to cross-divisional activities including but not limited to FAA, FSCA and/or Market Actions/ Investigational Product Field Actions as assigned.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs).
• The ability to fluently read, write, understand, and communicate in English.
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Work hours: Exempt
• Travel Requirements: up to 20% as needed.
• Relocation assistance: No
• Sponsorship available: No

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in science or technology.
• QA work experience in a regulated Medical Device / Pharmaceutical Industry.
• Strong R&D experience and knowledge, with manufacturing experience desired.
• Proven personnel management experience.
• Advanced knowledge of ISO 14155/ 14971, 13485, ICH 6, Medical Device and Pharmaceutical EU and FDA 21 CFR 820 / 211 regulatory requirements.
• Highly proficient in MS Office.
• Highly proficient in data analytics, critical thinking, and decision making.
• Proven influencing and negotiating skillset.
• Ability to lead virtual teams and function in a matrix organization, with project management experience desired.
• Advocate for exceptional Quality and Compliance Standards - does not compromise on customer expectations and regulatory requirements.

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.