Senior/Medical Director (Medical Monitor)

Job description preview

From Thermo Fisher Scientific’s original posting

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Purpose: Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Responsibilities: Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle. General Support: • Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to CRG’s corporate policies and SOPs/WPDs. • Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. • Provides therapeutic training and protocol training on assigned studies, as requested.…