Clinical Trials Oversight Specialist

4 days ago


Gainesville, Florida, United States Maxis Clinical Sciences Full time
About the Position

This role offers a competitive salary of approximately $115,000 per annum.

Role Summary

We are seeking a skilled Medical Director to lead our clinical trials operations. As a key member of our team, you will be responsible for providing medical oversight and guidance to ensure the success of our clinical trials.

Duties and Responsibilities
  1. Manage all medical aspects of contracted tasks across the pharmaceutical product lifecycle.
  2. Ensure tasks delegated to PVG are properly executed, adhering to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
  3. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
  4. Assist in writing and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete.
Requirements
  • MD or equivalent required; active medical licensure preferred.
  • Candidates should have at least one of the following: clinical experience in treating patients in the specialty or sub-specialty associated with their training (comparable to 3 years), suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (comparable to 3-5 years) in the industry, or direct experience in safety/Pharmacovigilance (comparable to 3 years).


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