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Merck KGaA Darmstadt Germany - Augusta, ME
posted 2 months ago
Full-time - Mid Level
Remote - Augusta, ME
Chemical Manufacturing
About the position
The Country Clinical Quality Manager (CCQM) is responsible for overseeing clinical quality management activities within the country, ensuring patient safety, high-quality data, and compliance with regulations for all company-sponsored clinical trials. This role involves implementing processes, identifying opportunities for improvement, supporting audits and inspections, and coordinating training activities.
Responsibilities
- Oversee all Clinical Quality Management (CQM) activities in the respective country/cluster.
- Implement local/global processes and procedures for clinical trials.
- Identify opportunities for process improvement and support continuous improvement initiatives.
- Support audits and inspections, as well as Quality Control and local training activities.
- Coordinate and oversee all Quality Control (QC) activities, including execution of the In-house Quality Control Plan.
- Manage and support activities during audits and inspections, including root-cause analysis and corrective actions.
- Communicate and escalate quality/compliance issues to local management and the Regional Clinical Quality Manager (RCQM).
- Lead local supplier qualifications and support quality issue resolution with suppliers.
- Support implementation of divisional compliance/privacy initiatives at the local level.
Requirements
- Bachelor's Degree or equivalent in a relevant health care area.
- Minimum of 6 years of relevant experience in clinical research, including direct field monitoring experience or management oversight.
- Deep knowledge of Clinical Trial processes, GCP, and related regulations.
- Solid track record in project management and delivery.
- Experience in leading cross-functional teams.
- Experience in Clinical Quality Management, including Quality Control Activities and Process Management.
Nice-to-haves
- Experience in managing audits and inspections.
- Experience in coordinating and delivering training sessions.
Benefits
- Health insurance
- 401k
- Paid holidays
- Flexible scheduling
- Professional development opportunities
