Clinical Project Manager
Core
Coordinate operational management of clinical development projects to develop compounds in line with medical/scientific standards.
Role type
Clinical Project Manager
Builds
Clinical development projects for pharmaceutical compounds
Domain
Pharmaceutical industry, Clinical Operations
Deliverable
client delivery
Required skills
Project management, SOP development and compliance, CRO/provider selection and management, clinical risk management, study registry registration, clinical trial supply coordination, eTMF management, budget management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Make operational decisions to ensure projects are initiated and completed on time, on budget, and to quality standards; Develop full synopsis and protocol based on the Study Outline; Contribute to CRO and/or Providers selection including RFP implementation and proposal review; Manage the Clinical CRO/Providers as primary contact; Collaborate in the set-up and maintenance of the Study Risk Register; Prepare and coordinate scientific meetings; Ensure registration of the study in public registries; Liaise with Clinical Trial Supply coordinator to define strategy and review labels; Manage the study eTMF and related activities; Account for overall completeness of the study eTMF and ensure archiving; Manage study budget and reconciliation.
Seniority
Mid-level, hands-on IC
