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Director Clinical Operations
2 months ago
Walker Cole International is seeking a Clinical Operations Director on behalf of a innovative Biotechnology business that have an exciting pipeline of clinical stage assets. The Clinical Operations Director is responsible for the planning, execution and conduct of clinical trials (sponsored and outsourced), and oversight of all clinical activity in the business.
Key Responsibilities:
- Assessment and selection of CRO's and other vendors, and work as the primary contact with vendors, measure performance using Key Performance Indicators.
- Manage and implementation of post authorisation and clinical trial protocols at trial sites
- Implement European risk management plans
- Oversight of site set-up, including submissions to local authorities, clinical study agreement and budgeting
- Ensure activities are conducted inline with GxP and all other study SOPs, respond to CAPA's and ensure trials are inspection ready.
The successful candidate will have:
- Degree, Masters or PhD in Life Sciences or Health Sciences
- Pharmaceutical industry experience within Clinical Trials
- Experience of leading Global Phase II or III (Late Phase) Clinical Study.
Global Clinical Project Manager | Clinical Trial Manager | Clinical Operations Manager | Clinical Trial | Oncology | Phase I | Phase 1 | Phase II | Phase 2 | Post Authorisation | Phase IV | Phase III | Phase 3 | Phase 4 | Director | CRO | Clinical Research Organisation | GCP | ICH | CAPA | Clinical Trial Protocols
