Associate Ccqm France
Il y a 2 mois
**Associate Country Clinical Quality Manager (Associate CCQM)**
It is critical that, for all of our clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Associate CCQM position has an important impact in achieving those objectives. Under the guidance of the Director, Country Clinical Quality Management Lead (CCQM Lead) and in close collaboration with the Country Clinical Quality Manager (CCQM), the Associate CCQM supports the oversight of specific CQM activities in the respective country/cluster.
The role requires the ability to properly support the implementation of local/global processes / procedures, the identification of opportunities for process improvement, and continuous improvement initiatives. In addition, the Associate CCQM supports audits, inspections as well as Quality Control and local training activities.
**Qualifications**:
- Bachelor's Degree or equivalent in relevant health care area.
**Experience**:
- A minimum of 4-6 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
- Knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
- Experience of participating in cross-functional teams of business professionals, Experience of leading a cross-functional team is a plus.
- Experience of participating in audits and inspections, preferably with experience of a direct support.
- Experience of coordinating and delivering training sessions is a plus.
**Skills**:
- Superior oral and written communication skills in an international environment.
- Good project management, organizational and prioritization skills.
- Good teamwork and leadership skills, including the ability to resolve conflicts.
- Ability to analyze, interpret, and solve problems.
- Ability to think objectively and with creativity and innovation.
**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, supports the CCQM in managing 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 CCQM Lead and/or Global Process Owners (if necessary).
- Supports continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and CCQM Lead and supports continuous improvements activities at the local/regional level.
**Training**:
- Supports local trainings (as needed).
**Quality Control (QC) Activities**:
- In conjunction with the local country operations management, supports the CCQM in the coordination, and oversight of 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, supports the CCQM during identification of local trends, root-cause-analysis (if necessary), and the development of local action plans (incl. sharing of results and training of local country operations, if required).
**Audits & Inspections**:
- Supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.
- In cooperation with local country operations and/or headquarters, supports 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, supports the CCQM during identification of local trends, root-cause-analysis (if necessary) and the development of local action plans (incl. sharing of results and training of local country operations, if required).
**Quality / Compliance Issue Escalation**:
- Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
- If indicated, escalates significant quality/compliance issues per company process and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
- Local POC for escalati
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