Overview

Summary

Position Summary

Under the general direction of the Director of Clinical Trials Office, the Manager of Clinical Trials Regulatory Affairs and Quality will have primary responsibility for oversight of the regulatory compliance of the Clinical Trials Office. This position is responsible for directing the work of the Clinical Trials Regulatory Affairs program and staff, manages resources and helps to plan and implement strategic direction for the department. The Manager of Clinical Trials Regulatory Affairs and Quality will perform all functions according to established policies, procedures, regulatory and accreditation requirements, as well as applicable professional standards

Required Minimum Knowledge, Skills, and Abilities (KSAs)

  1. Education: Bachelor’s Degree required. Master’s Degree preferred
  2. License/Certifications: Professional certification related to regulatory affairs. If none, must be obtained within 12 months of hire.
  3. Experience: A minimum of 5 years of relevant work experience; Management experience of regulatory affairs in a large-scale academic medical institution.
  4. Experience with monitoring and/or audits from a site, FDA, and/or Sponsor perspective.

Additional Information

Maine Medical Center is a Magnet designated 606-bed tertiary care and teaching institution. MMC is Maine’s largest hospital and a state-wide health care resource. MMC offers outstanding career opportunities and quality of life in Portland.

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