Clinical Compliance Manager - GCP
Philadelphia Metro Area, Pennsylvania
- Clinical Compliance Manager
- Responsible for assisting in the design and execution of global clinical compliance review plans, providing quality input on SOPs and clinical documents, conducting and auditing suppliers and qualification and compliance assessments
- Assisting in the development, implementation and closure of corrective and preventive actions (CAPA).
- Serve as Clinical Quality Lead on select program teams, facilitate the assessment and investigation of quality issues, provide guidance, support and training on global GCP standards and support clinical teams with regulatory inspections.
Essential job functions and duties
- Assist in the design, execution and tracking of global clinical compliance plans
- Provide quality review and input on SOPs and core clinical documents
- Conduct and/or oversee clinical site and vendor/subcontractor compliance assessments
- Assist Clinical Teams in the development of appropriate corrective & preventative action plans and track to completion
- Serve as Clinical Quality Lead on selected program/protocol teams
- Facilitate the assessment, investigation and tracking of quality issues, providing guidance and expertise
- Conduct research/surveillance on GCP regulatory standards and updates globally and provide expertise and training sessions
- Support Clinical Teams with regulatory agency inspection preparations, conduct and follow-up
- Minimum requirements
- Bachelor s degree preferably in life sciences or RN. Master s degree preferred. Other relevant experience may be considered in lieu of the above.
- 3-5 years of experience in clinical compliance and/or clinical quality auditing.