The Medical Monitor (MM) plays a critical role in overseeing the safety and efficacy of clinical trials, ensuring compliance with regulatory requirements, providing medical oversight, and performing medical data reviews to ensure patient safety and data integrity. Collaborates with Project Manager, Safety/Pharmacovigilance (PvG), Data Management, Biostatistics, QA, Principal Investigator and Sub-investigators, Site Coordinators, the Data Monitoring Committee (DMC), and any other group that directly or indirectly protects the safety of study participants.
Essential Duties and Responsibilities:Clinical Trial Medical Oversight: Provide medical, scientific, and safety oversight for clinical trials, ensuring protocol adherence, participant safety, eligibility, IP dosing, and management of AEs/SAEs/SUSARs, with 24/7 coverage and backup support as needed.
Safety Review & Risk Management: Lead and support ongoing safety data review, including medical coding, patient narratives, Risk Management Plans, MedWatch reporting, and collaboration with Safety/PvG, DMCs, and cross-functional teams.
Site & Investigator Support: Serve as the primary medical point of contact for investigators, site staff, and sponsors; participate in site selection, SIVs, investigator meetings, site visits, and protocol deviation and root-cause assessments.
Data & Document Review: Conduct regular medical review of clinical data, CRFs, medical plans, informed consent forms, and study documents; contribute to Investigator's Brochure content and interpretation of early-phase trial data.
Trial Design & Cross-Functional Collaboration: Provide medical input into protocol development and amendments, clinical development plans, study reports, and scientific presentations, working closely with Clinical Operations, Project Management, and other departments.
Training, Mentorship & Representation: Train and mentor staff on therapeutic area and clinical research principles, support proposals and commercial activities as needed, and represent the organization at professional meetings.
Qualifications:- Doctorate degree in medicine or Doctor of Psychology (Psy.D), preferrably with specialization in a CNS therapeutic area. Active license preferred but not required.
- Minimum 5+ years medical monitoring or study physician in clinical research, or similar position in pharamceutical industry or CRO. Some supervisory experience preferred. Specialized CNS knowledge helpful.
- Demonstrate effective leadership of other medical or clinical research colleagues and proficiency with data review activities and use of various technologies utilized to display data (e.g., listings, patient profiles, databases and systems, and/or data visualization tools).
- Advanced knowledge of FDA guidance regarding clinical research trials.
- Strong understanding of medical terminology and drug-names, clinical trial processes, GCP, and regulatory requirements.
- Able to interact with and train others and build constructive, trusting, and respectful working relationships with colleagues and clients at all levels.
- Proficient computer skills (Word documents and spreadsheets) and email.
- Excellent written and oral communications skills (and group presentations).
- Sound critical thinking and problem solving skills.
- Able to execute position responsibilities with minimum guidance.
- Time management and ability to prioritize.
- Customer focused and discplined approach to work.
- Able to present and discuss medical/scientific concepts.
- Meticulous attention to details.
- Fluency in written and spoken English.
- Ability to travel
