Senior Manager, Clinical Trial Management - CNS (Remote)
Job description
The Senior Manager, Clinical Trial Operations (Site Management Franchise Lead - CNS/Neurology) is responsible for providing on-time and quality delivery of site management services from assigned Clinical Research Associates within CNS.
RESPONSIBILITIES:
- Provide therapeutic and operational expertise throughout the program/project delivery lifecycle
- Ensure that projects within the Franchise are properly resourced
- Responsible for creating-collaborating with Therapeutic team to provide effective delivery strategies and solutions for Franchise projects and programs
- Act as main contact person for the Project management Franchise Lead
- Present at Proposal Defense/client meetings as needed to support new or ongoing business
- Ensure CRAs are trained on project specifics
- Ensure LCRAs are trained to support the clinical scope of work (which includes SOP review, QI/CAPA understanding, Clinical Monitoring Plan)
- Coordinate and collaborate, with WCT Global Quality Assurance, to provide training opportunities identified in CAPA information
- Manage the quality of assigned staff's clinical work
- Coordinate efforts between the Project Management, Site Management, and Study Start Up
- Establishing regular communication to include quality metric (SVR compliance, SDV metrics, on site metric discussion, etc.) and overall “health” of the projects (data query status, managing to the SOW, resource status)
- Conduct appraisal performance review for direct reports
REQUIREMENTS:
- Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and eight years of clinical research experience as a clinical research associate
- Two years more management experience
- Extensive experience in CNS/Neurology
- Travel required
- Passport required
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