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:
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
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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.
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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.
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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
