About this role
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. • Assists in writing (interpretation of safety and efficacy data) 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. • Contributes to departmental process improvement initiatives. Clinical Trial Support: • Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. • Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study. • Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites. • Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
Marketed Products Support: • Manages signal detection activities, generates aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities. • Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted. •Exercises wide latitude in determining objectives and approaches to critical assignments. Complete latitude for independent judgment in methods, techniques and evaluation criteria for obtaining results. •Serves as a consultant and spokesperson for the functional area or as an external spokesperson for the organization on highly significant matters. Creates formal networks with key decision makers.
Education / Experience •MD or equivalent required. Active medical licensure preferred. Candidates should have a combination of clinical experience and industry experience as follows: • Clinical experience in treating patients in the hema oncology or sub-speciality associated with the applicants training (comparable to 2 years) and one of the following: • Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or • Direct experience in safety/Pharmacovigilance (comparable to 2 years).
Job Knowledge and Complexity Having broad expertise or unique knowledge, uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways. Develops solutions to highly complex and unique issues that impact and address future concepts, products or technologies.