- Responsible for the overall operational setup and execution of clinical studies on one or more clinical projects/programs; from study concept through study completion (i.e., Clinical Study Report – CSR finalization).
- Management of study team across a matrix with assigned clinical operations and cross-functional study team members to ensure compliance and execution of deliverables within approved budget and timelines.
- Aware of both internal and external business environments with the ability to assess impact on clinical studies and make modifications as necessary.
- Manage the implementation, on-time execution and conduct of clinical studies; including the development of the Study Plan which includes key milestones, timelines; study costs, vendor selection and resource needs as well as ensuring quality and compliance.
- Provide input on clinical and regulatory documents as appropriate (e.g., Investigator’s Brochure (IB), CSR, Investigational New Drug (IND/IMPD), New Drug Application (NDA), Marketing Authorization Application (MAA), Annual Report and Development Safety Update Report (DSUR).
- Effectively communicate study progress and actively identify issues that potentially impact evaluable study data, ethical study conduct, Code of Federal Regulations or other local regulations/guidelines and International Conference on Harmonization/Good Clinical Practice (ICH-GCP) compliance and identify in Risk Evaluation/Mitigation format potential interventions or solutions to manage the issues.
- Develop and approve investigative site ‘per patient’ budget parameters and negotiate clinical study agreements along with budgets/contracts for third party vendors.
- 15+ years’ experience.
The Head of Clinical Operations will report directly to the Chief Medical Officer and will work closely the VP of Research & Development.Apply Online