Senior Data Manager
Senior Data Manager
Posted on :
25-02-2025
Employer Active
1 Vacancy
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Job Description
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
- 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
- Supporting with SOP development and process improvements
- Provide input into Proposals Budgets and Bid Defense meetings
- Clinical database lock
- 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/thirdparty audits/inspections of Data Management
- Shared responsibility for followup on and resolution of audit findings pertaining to Data Management
Training
- Training junior members of the team
- Projectspecific 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 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.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Key Skills
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