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Job Description
Qualifications
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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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Job Description
Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with Standard Operating Procedures. Works with management to maintain the consistent execution of quality global procedures and monitors workload and resource allocation. Supports the comprehensive development of junior supervised staff and encourages effective interaction of Data Management Center staff with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of Global Data Operations deliverables at the trial level.
Education:
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Knowledge and Skills:
Four years’ experience in data management, medical research, or database design and development is preferable. Extensive start-up and in-life data management experience is required. Knowledge of database structures and available tools to manage, extract, and report data is preferred. Fluent Oral and written English language skills. Knowledge of applicable regulations and policies. Proficient overall working knowledge of the clinical development process.
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
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Hazardous Material(s):
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We are hiring for:
Clinical Program ManagerType:
CredentialedIf you are a positive and personable individual looking for a satisfying and fun opportunity to make a real difference in the lives of people with intellectual, developmental disabilities, and people facing mental health, and substance use challenges, join our team at RHA Health Services!
Provides clinical and programmatic oversight and supervision to Qualified Professional, Team leaders, Licensed Clinical Professionals who are providing behavioral health services on regional basis. Provides on-call and first responder consultation in the event of consumer crisis. Assists in the evaluation of high risk behaviors on an emergent and routine basis. Relies on extensive expertise, knowledge, experience, and judgment to supervise the clinical operations of a unit or a region. Requires an unencumbered license from a governing board regulating a human service profession. Typically reports to the Clinical Director.Pay: $75,000-$80,000
Job Responsibilities:
Job Requirements:
Pre-employment screening:
We offer the following benefits to employees:
*contract/contingent workers and interns do not qualify for any of the above benefits
EEO Statement RHA is an equal opportunity employer. In addition, we provide reasonable accommodation to qualified employees who have protected disabilities to the extent required by applicable laws, regulations, and ordinances. If you are an individual with a disability and need a reasonable accommodation to participate in the application process, please contact our solutions center.
About RHA:
At RHA Health Services, we help individuals with intellectual and developmental disabilities, mental health and/or substance use needs live their best lives. Our mission is to provide a safe and healthy environment while creating opportunities for personal outcomes.
For over 30 years, the people we serve and support have remained at the very center of everything we do. RHA currently provides services in North Carolina, Georgia, Pennsylvania, Tennessee, and New Jersey.
If you are ready to make a difference in the lives of people we serve and support apply to join the team today.
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Pfizer UK Undergraduate Programme 2024/2025
Junior Clinical Data Manager - Undergraduate
Global Product Development/Global Biometrics & Data Management (GBDM)
Clinical Data Sciences (CDS)
Who can apply?
Applicants must be completing placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year.
Please note that we only accept application forms. Please do not send over your CV or cover letter as they will not be considered. Please access the Word version of the Application Form here: Undergraduate Vacancies | Pfizer UK and find instructions as to how to complete your application and more about eligibility criteria. Learn more about this exciting opportunity below!!
Department Overview
Clinical Data Sciences is the function that manages the collection of clinical trial data and prepares it so it can be used for analysis to support a regulatory submission. It combines the disciplines of medical and scientific knowledge with IT skills including database design and system validation.
The CDS department is responsible for data management within Pfizer and ensures all clinical data is collected and managed to Good Clinical Practice and all associated regulations. CDS’s purpose is to deliver the right data, with integrity, on time, every time.
What can I achieve and what will I be responsible for whilst completing a placement at Pfizer?
As part of the Clinical Data Sciences group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Junior Data Manager is accountable for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio. The Junior Data Manager executes on key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data..
Pfizer also offers a diverse environment which allows employees numerous opportunities to grow and develop. This is a great chance to be part of the bigger picture, and to obtain a better comprehension of the pharma industry and the type of roles it has to offer.
Other tasks will include:
• Participate in CDS activities including data review and query management, ensures quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
• Assist with work carried out in accordance with applicable SOPs and working practices.
• Assist with the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
• Assist with operational excellence in partnership with Data Manager and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.
What other opportunities and benefits do Pfizer offer?
As well as learning the processes of data management within a regulatory environment, there will also be the option to develop personal skills while working within a global, cross-functional business environment. There will be the opportunity to build skills that have application within the pharmaceutical industry and beyond.
When can I start?
Placements will start on 2nd September 2024 and will run for 12 months.
PERSON SPECIFICATION
Type of person we are looking for, in relation to ‘Skills’, ‘Knowledge’ and ‘Motivation’:
Who can apply?
Applicants must be completing placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year.
This position will close for applications on 31st March 2024
Just a reminder re who can apply….
Applicants must be completing placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year.
Please note that we only accept application forms. Please do not send over your CV or cover letter as they will not be considered.
Please access the Word version of the Application Form here: Undergraduate Vacancies | Pfizer UK and find instructions as to how to complete your application and more about eligibility criteria.
#LI-PFE
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
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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.
The Technical Project Manager is responsible for the oversight and management of the end-to-end delivery of technical data management components for one or more drug/vaccine programs. Provides technical consultation on the data management strategy, collaborates with appropriate functional areas to secure and align resources, and ensures all aspects of the technical project plan for in-scope studies are executed on time and with quality. Supports less experienced Technical PMs in the development of project plans which span from design and specification development through production deployment and subsequent change management support.
Minimum education required:
B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Required experience and skills:
A minimum of 3 years of experience working with formal project management tools and processes.
In-depth knowledge of the clinical development process, preferably through submission.
Thorough knowledge of clinical data management; demonstrated knowledge of technical processes inclusive of electronic Case Report Form (eCRF) development, clinical database development, data validation tool development, user acceptance testing, data integration from different sources, data flow/migration, and application of CDASH and SDTM standards is preferred.
Experience using project management tools such as Microsoft Project.
Demonstrated leadership and project management skills, strong organization, communication, negotiation, and problem-solving skills. Strong customer-focus and interacts effectively with different functional groups.
#EligibleforERP
#ONEGDMS
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:
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:
$111,400.00 - $175,300.00Available 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
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