Country Clinical Quality Manager, Remote

Merck • Rahway, NJ

9h • $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 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 delivery of 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 (incl. impact assessment of new/updated local regulations on local processes).
• 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.
• Clinical Research
• Clinical Trials
• 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 International Council for Harmonisation Good Clinical Practice (ICH-GCP) and local regulations.
• Manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes.
• Ensures proper implementation of global/local processes and regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
• Identifies process gaps / opportunities for process improvement and escalates them.
• Leads continuous quality improvements activities at the country level.
• Acts as the local training point of contact and liaison between local country operations and the Research & Development Division Learning & Development (L&D).
• Identifies and coordinates local training needs.
• Supports local trainings.
• Coordinates and oversees all Quality Control (QC) activities.
• Ensures 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.
• Identifies local trends, performs root-cause-analysis, and develops local action plans.
• Serves as the primary local point of contact for 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 to management.
• Escalates significant quality/compliance issues and supports investigations.
• Serves as local POC or supports local POC in case of escalations/reporting of Privacy Incidents.
• 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.
• 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.
• Supports global/regional key initiatives/projects upon request.

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