Function as the medical expert for assigned clinical studies which includes being available to advise on related medical questions/issues during study conduct.
May 17, 2023
Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.
November 11, 2022
Participates in protocol review for safety input such as requirement of a CEC or DSMB, adverse event reporting requirements and endpoint determination.
November 29, 2022
Requires a PharmD with a minimum of 5-8 years industry experience in drug development and clinical research (MD preferred.
December 30, 2022
Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings.
March 04, 2023
Communicates potential and known risks to Management, Quality Assurance, Regulatory Affairs, and Clinical Affairs personnel.
March 09, 2023