Description
- Project Manage the delivery of EDC and Integrations between vendors and Data Manager/Study Team
- Project Manage all clinical programming activities for the life of the project.
- Subject Matter Expert on EDC platform and related technologies (e.g. Coding, Lab Admin, JReview, SAS)
- Involved in RFP development, contract negotiation and selection of DM and/or technology, as needed Escalate issues with proposed solutions, as necessary
- Establish and negotiate timelines with internal and external team members for completion of activities for a project
- Ensures documentation and archival standards of deliverables including DM systems, databases, programs, and specifications
- Ensures guidelines and specifications on validation procedures and data transfer procedures are followed. Maintain appropriate documentation surrounding maintaining or archiving clinical data and/or programs
- Applies and promotes consistent programming standards through processes, guidelines, and SOP
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