Our client seeks a Clinical Research Operations professional to plan their Phase I Clinical Trials
- Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.
- Ability to travel as required (up to 25%).
- 12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff.
- Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to the conduct of regulated clinical trials.
- Comprehensive understanding of applicable clinical research regulations. Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
- Oversee the company’s Clinical Operations activities and implementation of clinical studies and development programs.
- Ensure operational feasibility of clinical development plans, including timeline, budget and resource requirements.
- Ensure that all activities are completed in accordance with ICH GCP regulations, health authority regulations and SOPs.
- Set the direction of the Clinical Operation organization and lead strategic discussions regarding program and study resourcing.
- Hire, supervise and train operations personnel and assume ownership of the quality of clinical deliverables.
- Procure CRO and vendors and provide oversight throughout the life of all assigned activities. Ensure transparency for costs, deliverables and quality expectations.
- Define patient recruitment strategies and ensure operational feasibility and timely implementation of the set study goals.
- Work with other Medical/Clinical team members on study documents including clinical trial protocol and amendments, ICFs, CRFs, IND, IB, CRO contracts, study reports, etc.