Senior Data Manager
3 settimane fa
The Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies.
Communication
- Provide general oversight on all Data Management activities on large complex global studies.
- Act as the communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting.
Data Management
- Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.
- Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
Reviews and Approvals, Escalation Point and Troubleshooting
- Involved in audits and inspections.
- Support with SOP development and process improvements.
- Provide input into Proposals, Budgets, and Bid Defense meetings.
- Coordination and supervision of processing, dispatch, and archiving of CRFs/queries.
- Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol.
- Development of CRF completion guidelines.
- Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required).
- Electronic data transfer (import/export) specifications review and approval.
Quality Control
- Database QC checks performance and documentation.
- Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management.
- Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management.
Training
- Training junior members of the team.
- Project-specific training of investigators and clinical team in CRF completion.
Qualifications
- College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities.
- Significant experience of the full scope of data management responsibilities in international EDC studies.
- Experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable).
- Organizational and managerial skills.
Additional Information
Advance your career in clinical research and develop new skillsets whilst growing with the organization.
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