Full-Time Senior Data Manager

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

Communication

• Provide general oversight on all Data Management activities.
• 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.
• 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

Requirements

• College or University degree or equivalent combination of training and experience
• 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

Career Development

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

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