Full-Time Lead Data Manager

Lead Data Manager is responsible for all data management activities in assigned clinical trials under supervision.

Primary Communication Point:

• Project teams and company departments regarding clinical data management
• Clients/vendors for all data management aspects of clinical projects

Data Management Activities:

• Coordinates data management activities within clinical projects related to:
• EDC development
• Data collection
• Cleaning
• Reconciliation
• Database Lock
• Development of final integrated database
• Generation of final Data Management deliverables

Project Management: Provides input into monitoring of project scope, budget, timelines, and deliverables.

Responsibilities:

• Study Documentation Development:
• eCRF Requirements
• Edit Checks Specification
• Data Management Plan
• CRF Completion Guidelines
• User Access Management Plan
• Data Validation Plan
• External Data Transfer Agreements
• SAE Reconciliation Guidelines
• Local Lab Normal Ranges Guidelines
• Coding Guidelines (where applicable)

• User acceptance testing
• User access management
• Data review
• eCRF/External data reconciliation
• Medical coding (for staff with medical/Life Science background)
• SAE reconciliation
• Query management
• Study Database Lock activities
• Archival of CRFs
• QC Coordination
• Project status reporting
• Data listings/Patient profiles generation
• Maintains and QCs TMF/eTMF as well as Data Management working files
• Trains Data Managers and Assistant Data Manager
• Conducts project-specific training

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