Director, Clinical Compliance (GCP)
City Of London, England, United Kingdom
Hybrid / WFH Options
Hybrid / WFH Options
Proclinical Staffing
Proclinical is seeking a dedicated and proactive Director of Clinical Compliance. This role focuses on establishing and implementing a Quality Strategy for clinical development activities. The successful candidate will ensure all work is in agreement with regulatory requirements and will adherence to Good Clinical Practices. This … alternatively can be a hybrid working role based in Mainz, Germany. Responsibilities: Provide strong QA leadership, fostering organizational awareness and interdepartmental collaboration. Implement the Clinical Development Quality Plan within the development portfolio. Provide robust quality oversight in various areas, including risk detection and remediation. Offer guidance on day-to … CAPA preparation. Lead a team to ensure a unified approach to proactive support for clinical trials. Key Skills and Requirements: Experience in a GCP Environment within the Pharmaceutical or CRO Industry. In-depth knowledge of worldwide regulations (including FDA, EMA) related to clinical development and post-approval. Experience more »
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