Full-Time Lead Data Manager

Lead Data Manager Responsibilities:

Responsible for all data management in large, complex studies (general supervision) or small to medium projects (minimal supervision).

Communication:

• Primary communication point for project teams and company departments regarding clinical data.
• Communication line for clients/vendors for all data management aspects.

Data Management:

• Coordination of data management activities (EDC development, collection, cleaning, reconciliation, database lock, final database, deliverables).
• Primary responsibility for clinical data management, including:
• Study documents review
• Data Management plan development/review
• User acceptance testing coordination/performance
• Data Validation Plan/Edit Check Specifications development
• Data entry coordination/supervision
• Data validation (manual/automatic inspections, discrepancy/deficiency review)
• Query generation/resolution
• Feedback to clinical trial teams
• Non-CRF electronic data handling
• Database edits (paper CRF studies)
• Manual CRF review
• Clinical database lock coordination
• CRF/query processing, dispatch, and archiving coordination
• Input into CRF/data collection form design; review for accuracy
• CRF completion guidelines development
• Medical data coding (coding dictionaries/listings review)
• SAE reconciliation
• Electronic data transfer specifications review/approval

Document Management:

• Liaison with Document Center for TMF/eTMF maintenance.

Quality Control:

• Database QC checks performance and documentation.
• Shared responsibility for internal/client audits.
• Follow-up/resolution of audit findings.

Training:

• Assistant Data Managers training
• Project-specific investigator/clinical team training.

Corporate/Departmental:

• Investigator Meetings preparation/attendance
• Client/vendor meetings/teleconferences preparation/attendance

Qualifications:

• College/University degree or equivalent experience.
• Minimum 3 years experience in international EDC studies.
• Minimum 2 years experience using CDM/EDC systems.

Additional:

• Project data management experience
• Organizational/managerial skills

Career Advancement:

• Advance your career in clinical research and develop new skillsets.

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