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:
o Reviews and approvals, escalation point and troubleshooting
o Involved in audits and inspections
o Supporting with SOP development and process improvements
o Provide input into Proposals, Budgets and Bid Defense meetings
o Clinical database lock
o 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 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.