Merck Country Clinical Quality Manager, US - Remote
It is critical that, for all company-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 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 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 our Research 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 quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
Serves as local POC or supports local POC in case of escalations/reporting of Privacy Incidents, if applicable.
Clinical Supplies GCP Investigations:
Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).
Leads local supplier qualifications and re-qualifications of locally selected suppliers and supports solving of quality issues with locally selected suppliers.
Supports the Quality Management System (QMS) assessment for local supplier qualifications and re-qualifications.
Research Division Compliance & Privacy Steward:
Supports implementation of divisional compliance/privacy initiatives and reporting at the local level.
Communicates compliance/privacy concerns to local legal/compliance/privacy department and/or our Research Division's Compliance/Global Privacy Office.
Global / Regional Key Initiatives / Projects:
Supports global/regional key initiatives/projects upon request of the RCQM.
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