The Study Manager’s primary responsibility is to coordinate and manage all company contracted services in assigned global study(s), providing quality service, and exceeding the expectations of customers. The Study Manager manages the key global relationships and communication among all internal and external stakeholders involved in a study, and keeping all stakeholders informed in a timely and professional manner about the progress and key events with the study.
- Accurately identify issues and creatively resolve problems while correcting processes as needed.
- Coordinate, administer and document all study management activities.
- Maintain and adhere to study project plans and timelines.
- Train subcontracted resources, country study managers, nurses or other clinicians.
- Provide support and guidance for subcontracted resources, including routine teleconferences to review progress to timelines, issue management, and information sharing.
- Contact country study managers and/or clinicians to ensure visits are scheduled and have occurred per the required timelines.
- Review study documentation to ensure completeness, accuracy and timeliness.
- Ensure CRM is updated and reports are reviewed and provided to the appropriate stakeholders timely and according to expected timelines.
- Solicit information to support inquiries from all stakeholders.
- Support all internal and external team members in their efforts to support the study.
- Participate/Lead study team reviews with country study managers.
- Act as the liaison between the sponsor, CRO, investigative site staff, laboratory, pharmacy and other internal and external personnel as the study requires.
- Previous experience working in a Clinical Research role, such as Clinical Research Coordinator, Clinical Research Associate, or Clinical Study Manager
- Detail-oriented; and process-oriented
- Able to work independently or as an effective member of a team
- Able to identify problems and propose a resolution
- Committed to ensuring quality results: Able to produce quality and timely results
- Demonstrates the ability to build strong positive relationships with others internally and externally
- Demonstrates sound judgment and decision-making ability
- Demonstrates strong communication skills (written and verbal)
- Understands and demonstrates compliance with ICH/GCP, HIPAA, IATA, Data Privacy, company SOP’s and other regulations as appropriate
- Applies project management principles to daily activities