Clinical QA Managing Consultant - GCP
Wayne Metro Area, New Jersey
- Clinical QA Management Consultant
- BS, MS, RN or related with at least 3 years of experience in clinical quality management and compliance:
- Execute 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.
- 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
- Clinical SOP development, updating Standard operating procedures and preparing reports such as PSUR, DSUR,
- GCP Quality Auditing
- TMF auditing
- GCP compliance management, and supporting / oversight of compliance of external CRO or related clinical suppliers