Full-Time Senior Data Manager

Senior Data Manager will oversee all data management activities in large, complex studies.

Responsibilities:

• General oversight of all Data Management activities.
• Communication with clients/vendors on all data management aspects.
• Coordination of data management activities including EDC development, data collection, cleaning, reconciliation, Database Lock, integrated database development.
• Primary responsibility for reviews, approvals, escalation, troubleshooting of clinical data management.
• Involved in audits and inspections, SOP development and process improvements.
• Input into Proposals, Budgets, and Bid Defense meetings.
• Coordination and supervision of CRF/query processing, dispatch, archiving.
• Input into CRF design, review for accuracy and adherence to protocol, and CRF completion guidelines.
• Medical data coding with dictionaries and listings review.
• Review and approval of electronic data transfer specifications.
• Database QC checks performance and documentation.
• Shared responsibility for internal and client audits/inspections.
• Shared responsibility for follow-up and resolution of audit findings.
• Training junior team members and investigators/clinical team on CRF completion.

Requirements:

• College or University degree or equivalent.
• Significant experience in international EDC studies.
• Experience with CDM/EDC systems (Medidata Rave or Oracle Inform).
• Organizational and managerial skills.

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