Country Clinical Quality Manager, US - Remote

Job Description

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:

• Pri