JOB SCOPE Role : Clinical Project Lead • Leads/supervises a team of more than 2 professionals within the Medical Affairs Sub-Function. • First level manager of a work team that may comprise professionals, technical and/or administrative staff. • Typically without budget or hire/fire authority. • Focuses on mentoring, coaching, and coordination. JOB REQUIREMENTS • As the Supervisor of the Medical Affairs Sub-Function, supervises professionals in overseeing the direction, planning, execution, clinical trials/research and the data collection activities. • Contributes to implementation of clinical protocols, and facilitates completion of final reports. • Recruits clinical investigators and negotiates study design and costs. • Responsible for directing human clinical trials, phases III & IV for company products under development. • Participates in adverse event reporting and safety responsibilities monitoring. • Coordinates and provides reporting information for reports submitted to the regulatory agencies. • Monitors adherence to protocols and determines study completion. • Coordinates and oversees investigator initiations and group studies. • May participate in adverse event reporting and safety responsibilities monitoring. • May act as consultant/liaison with other corporations when working under licensing agreements.