- 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
- 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 troubleshootingInvolved in audits and inspectionsSupporting with SOP development and process improvementsProvide input into Proposals, Budgets and Bid Defense meetingsClinical database lockCoordination 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
- 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 junior members of the team
- Project-specific training of investigators and clinical team in CRF completion
- 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)
- Full working proficiency in English
- Organizational and managerial skills
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Senior Data Manager - Shanghai, 中国 - PSI
描述
Job Description
The Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies.
Communication
Data Management
Quality Control
Training
Qualifications
Additional Information
Advance your career in clinical research and develop new skillsets whilst growing with the organization.
