Clinical Trial Manager - Clinical Trial Manager 2
Hybrid - Multiple Locations
$100,000 - $140,000 Annual Salary Based on Experience; Sign On Bonus Eligible
The CTM is an experienced study team leader responsible for the clinical trial management operational delivery of assigned clinical projects through reporting, including inspection readiness and risk management, and in alignment with the program strategies. The CTM is an expert on the operational strategy of clinical trials, leads Sponsor communication and study deliverables, and is responsible for developing the study timelines and management of the study budget. The CTM leads and manages the internal cross-functional study team and provides regular status reports to internal & external key stakeholders, including the program team and senior management.
Responsibilities include but are not limited to:
Responsible for the clinical trial management operational delivery of assigned clinical projects through reporting, including inspection readiness and risk management, and in alignment with the program strategies.
Vendor management & oversight when needed.
Maintain & improve study protocol.
Serve a primary Point of Contact for Sponsor company for all operational information for assigned projects.
Cross functional oversight of assigned projects & programs, ensuring deliverables are being met in timely manner.
Providing needed training to ensure deliverables are properly met.
Tracks study progress and proactively escalates project-related issues, including those related to time, and quality, to the key internal stakeholders to ensure timely resolution of issues.
Ensures comprehensive operational input to protocol design & operations project plans.
Oversee site quality & monitoring to ensure deliverables.
BS/BA degree or equivalent in health related field. An advanced degree is preferred.
2+ Years as a Clinical Trial Manager or Project Manager within a CRO - CRO experience is required.
Managing clinical trials & projects.
Strong understanding of ICH, GCP, and relevant regulatory requirements
Global clinical trial conduct and clinical operations experience, from start-up to database lock. A thorough understanding of the processes associated with project and study management.
Experience in Phases 1-4 of development.