Country Clinical Quality Manager, Remote

Merck

Rahway, NJ

Estimated pay: Est. $21–$32/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 Country Clinical Quality Management Lead, the CCQM oversees all Clinical Quality Management (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, Skills Experience Qualifications Bachelor s Degree or equivalent in relevant health care area. Experience 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. Experience in Country Operations preferred. Deep knowledge and understanding of Clinical Trial processes, Good Clinical Practice (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. Functional Area Regulations Processes Local expert for International Council for Harmonisation Good Clinical Practice (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 CCQM Lead, Regional Director, Clinical Quality Management (RCQM) and/or Global Process Owners (if necessary). Leads continuous quality improvements activities at the country level as agreed with Country/Cluster Country Research Director (CRD); CCQM Lead and Regional Director, Country Quality Manager (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 Quality Control (QC) Checks. In mutual agreement with local country operations management, CCQM Lead, and the RCQM, performs Quality Control (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 neces