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Director, Clinical Research Operations
Job Opportunity at
MEIRxRS / Med Exec Intl
Posted on Nov 23
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.
Day to Day Responsibilities
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.
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