2018-11-23

Director, Clinical Research Operations
Job Opportunity at MEIRxRS / Med Exec Intl

Posted on Nov 23

https://meirxrs.com    818-247-1368

Location: Menlo Park, CA
Job Type: Full Time
Job ID: W4162527

Our client seeks a Clinical Research Operations professional to plan their Phase I Clinical Trials

Requirements
 
  • 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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