Country Clinical Quality Manager, Remote

MSD • Rahway, NJ

1d • $142,400 - $224,100 • Remote

About The Position

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.

Requirements

• Bachelor's Degree or equivalent in a relevant health care area.
• 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.
• 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 delivering projects and knowledge of project management practices.
• Demonstrated experience in leading cross-functional teams.
• 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.
• Local expert for International Council for Harmonisation Good Clinical Practice (ICH-GCP) and local regulations.
• No direct reports.

Nice To Haves

• Experience in Country Operations preferred.
• 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.
• Experience in Clinical Research.
• Experience in Clinical Trials.
• Experience in Continuous Improvement.

Responsibilities

• Oversees all Clinical Quality Management (CQM) activities in the respective country/cluster.
• Implements local/global processes/procedures.
• Identifies opportunities for process improvement and supports continuous improvement initiatives.
• Supports audits, inspections, Quality Control, and local training activities.
• Acts as the local expert for ICH-GCP and local regulations, including impact assessment of new/updated local regulations on local processes.
• Manages the local network of owners/Subject Matter Experts (SMEs) for global/local processes to ensure proper implementation and regular update of local SOPs/WIs.
• Identifies process gaps and opportunities for process improvement, escalating them to the CCQM Lead, Regional Director, Clinical Quality Management (RCQM), and/or Global Process Owners.
• Leads continuous quality improvements activities at the country level as agreed with Country/Cluster Country Research Director (CRD), CCQM Lead, and RCQM, and supports or co-leads continuous improvements activities at the global/regional level.
• Serves as the local training point of contact and liaison between local country operations and the R&D Division Learning & Development (L&D).
• Identifies and coordinates local training needs in cooperation with local country operations management.
• Supports local trainings as needed.
• Coordinates and oversees all QC activities in conjunction with local country operations management, ensuring proper execution of the In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs), and other QC Checks.
• Performs Quality Control (QC) activities, including QCVs, and conducts ad hoc site visits upon request, in mutual agreement with local country operations management, CCQM Lead, and the RCQM.
• Identifies local trends, performs root-cause-analysis, and develops local action plans, including sharing of results and training of local country operations.
• Serves as the primary local point of contact for R&D Division Quality Assurance and Regulatory Agencies.
• Manages and supports activities during the preparation, ongoing, and follow-up phases of an audit or inspection.
• Performs root-cause-analysis for audit observations/inspection findings, manages and tracks Corrective and Preventive Actions (CAPAs), and coordinates/facilitates responses to audit/inspection reports.
• Communicates/escalates quality/compliance issues (including potential trends) to local country operations management, CCQM Lead, and RCQM.
• Escalates significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) and reporting of ‘Serious Breaches’, if applicable.
• Serves as local POC or supports local POC in case of escalations/reporting of Privacy Incidents, if applicable.
• 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.
• 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.
• 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 R&D Division Compliance/Global Privacy Office.
• Supports global/regional key initiatives/projects upon request of CCQM Lead and/or the RCQM.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days
• Annual bonus
• Long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior