Full-Time Lead Data Manager

Lead Data Manager Responsibilities:

Responsible for all data management activities 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 management.
• Communication line for clients/vendors for all data management aspects of clinical projects and reporting.

Data Management:

• Coordinate data management activities (EDC development, data collection, cleaning, reconciliation, database lock, final database, and deliverables).
• Primary responsibility for clinical data management activities, including:
• Study documents review
• Data Management plan and project-specific guidelines development and review
• Coordinate/perform user acceptance testing
• Develop Data Validation Plan/Edit Check Specifications
• Data entry coordination and supervision (feedback on data quality)
• Data validation (automatic and manual inspections, discrepancies/deficiencies review, query generation and resolution, feedback to clinical teams).
• Non-CRF electronic data handling (receiving, archiving, loading, reconciliation issues, feedback to vendors)
• Database edits (paper CRF studies)
• Manual CRF review (non-medical checks)
• Clinical database lock
• Coordination and supervision of CRF/query processing, dispatch, and archiving
• Input into CRF and data collection form design; review Case Report Form design for accuracy and adherence to protocol
• Develop CRF completion guidelines
• Coding medical data with coding dictionaries and listings review
• SAE reconciliation
• Electronic data transfer specifications review and approval

Document Management:

• Liaison with Document Center regarding TMF and eTMF maintenance.

Quality Control:

• Database QC checks performance and documentation.
• Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections.
• Shared responsibility for follow-up on and resolution of audit findings.

Training:

• Assistant Data Managers training
• Project-specific training of investigators and clinical team in CRF completion

Corporate/Departmental Assignments:

• Investigator Meetings preparation/attendance
• Meetings and teleconferences organized by client/vendor preparation/attendance

Qualifications:

• College or University degree or equivalent
• At least 3 years of experience in international EDC studies
• At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferred)
• Project data management experience is a plus
• Organizational and managerial skills

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