•Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies.
•Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department.
•Responsible for protocol design and development, upon request. Provides input into protocol amendments.
•Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed.
•Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts. This activity includes, but is not limited to, review of Informed Consent Templates and Subject-Facing Materials, and input into site feasibility evaluations.
•Provides medical input into data collection tools, monitoring plans, and review and analysis plans.
•Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data. Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data.
•Provides after-hours medical coverage for clinical studies.
•Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.
•Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
•May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request.
•May provide input to clinical development or regulatory teams within the Company, upon request.
•May represent the Company at scientific meetings, upon request.