Country Clinical Quality Manager, Remote

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 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, CCQM Lead, 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 Point of Contact (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).

Supplier Qualification

• 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.

Our Research & Development 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 & Development Division Compliance/Global Privacy Office.
• Regional Key Initiatives / Projects
• Supports global/regional key initiatives/projects upon request of CCQM Lead and/or the RCQM.

Job Family Clinical Research Generic

• Management or Individual Contributor
• No direct reports
• Geographical Scope US

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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