It is critical that, for all sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The ccqm position 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.
qualifications:
- bachelor's degree or equivalent in 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, good clinical practices 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.
*skills*:
- superior oral and written communication and leadership skills in an international environment. Excellent project management and organizational 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.
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 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 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 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, 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 our research & development division 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 qualit