It is critical that patient safety, high-quality data, and compliance with company requirements and regulations are delivered and sustained for all company-sponsored clinical trials. The CCQM position significantly impacts 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, identify opportunities for process improvement, and support continuous improvement initiatives. In addition, the CCQMs support audits, inspections, Quality Control, and local training activities.
Functional Area
Regulations & Processes:
- Local expert for ICH-GCP and 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 (WIs).
- 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 improvement activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvement activities at the global/regional level.
Training:
- Be the local training point of contact and the liaison between local country operations and the R&D department's Learning & Development (L&D).
- In close cooperation with local country operations management, identifies/coordinates local training needs.
- Supports local trainings (as needed).
Quality Control (QC) Activities:
- In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes ensuring 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, 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 the R&D department's 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 a 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
Qualifications:
- Bachelor's Degree or equivalent in a relevant health care area.
Experience:
- 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 delivering 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.
Skills:
- 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.