Country Clinical Quality Manager - CCQM

Merck

Estimated pay: Est. $19–$29/hr (market estimate, not employer-stated)

Shift: Full time

Job Description It is critical that, for all our company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Country Clinical Quality Manager (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, GCP 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, 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. 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 our Research Development Division 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 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. • Esc