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/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
- 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
Advance your career in clinical research and develop new skillsets whilst growing with the organization.
