KI
Clinical Data Management
- Hiring from
- Probably Worldwide
- Work type
- Remote
- Posted
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Job Description
This is a remote position.
Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards. Leadership, Direction, and Strategy: Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies with less complexity. Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies with less complexity. Project Management: Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting). Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.