Senior Specialist, Clinical Trial Management
Organon
Full-time
Remote friendly (Plymouth Meeting, PA)
United States
Clinical Research and Development
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Senior Specialist, Clinical Trial Management. The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) supports operational aspects of phase 1 & phase 2a studies, coordinating with TMED Operations to plan and execute studies, manage timelines, and serve as the primary contact for vendors.
Responsibilities
- Manage and support the operational aspects of clinical studies from study start-up through close-out.
- Serve as the point of contact for study-related vendors (CROs, sites, and other vendors) to execute TMED studies within contracted scope, costs, and timelines.
- Engage with vendors to define, monitor, and report on key trial performance indicators (e.g., country/site initiation, screening and randomization rates, data collection).
- Coordinate cross-functional communication and documentation to optimize collaboration and ensure compliance with the protocol, ICH/GCP, and regulatory requirements.
- Identify and communicate risks; develop and implement risk mitigation strategies to enable study completion on approved timelines.
Qualifications
- Bachelor’s degree or higher in natural or health sciences (pharmacology, biology, nursing, or related fields).
- 5–6+ years in translational medicine and early clinical development within pharma/biotech, with a track record in overseeing TMED (early phase 1–2a) studies.
- Excellent organizational, project management, and cross-functional collaboration skills.
- Working knowledge of GCP, ICH, and regulatory standards.
- Strong technical writing skills; ability to summarize clinical and scientific information accurately.
- Proven experience representing on product development teams; strong verbal and written communication.
- Collaborative, inclusive leadership of cross-functional teams; proficient with MS Word, PowerPoint, and Excel.
- Experience contributing to SOP working groups and process-related teams; Women’s Health experience preferred.
Skills
- Phase 1 study operations
- ICH/GCP
- Clinical research
- Clinical development
- Vendor selection and management
Education
- Bachelor’s degree or higher in natural or health sciences (pharmacology, biology, nursing, or related sciences).