Country Clinical Quality Manager

hace 2 semanas


Xico, México Msd A tiempo completo

Msd is seeking a highly skilled Clinical Quality Manager to oversee all Clinical Quality Management activities in the respective country/cluster. This role plays a critical part in ensuring the delivery and sustenance of patient safety, high-quality data, and compliance with company requirements and regulations.

The Clinical Quality Manager will be responsible for the proper implementation of local/global processes/procedures, identifying opportunities for process improvement, and supporting continuous improvement initiatives. This includes managing audits, inspections, Quality Control activities, and local training.

Key qualifications for this role include:

  • Bachelor's Degree or equivalent in a relevant healthcare area
  • A minimum of 6-8 years of 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 Practices, and other clinical research-related regulations
  • Solid track record of initiating, planning, and delivering projects, as well as knowledge of project management practices
  • Experience in leading cross-functional teams and managing audits and inspections

The ideal candidate will possess:

  • Superior oral and written communication and leadership skills in an international environment
  • Excellent project management and organizational 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

This role requires local expertise in ICH-GCP and local regulations, as well as the ability to identify process gaps and opportunities for process improvement. The Clinical Quality Manager will also be responsible for leading continuous quality improvement activities at the country level and supporting or co-leading continuous improvement activities at the global/regional level.

Additionally, the Clinical Quality Manager will serve as the local training point of contact and liaison between local country operations and Learning & Development. They will identify and coordinate local training needs, support local trainings, and oversee all Quality Control activities, including the In-house Quality Control Plan and Quality Control Visits.

As a key member of the Msd team, the Clinical Quality Manager will communicate and escalate quality/compliance issues to local country operations management and the Regional Director, Clinical Quality Management.



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