Responsibilities:

Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents.
Interact effectively with sponsors and oversee vendors.
Develop SOPs and study-specific procedures.
Manage Data Management tasks from study start-up to database lock for assigned studies.
Lead multiple large and complex studies, delegating tasks as needed.
Work with DB programmers to design (e)CRFs and edit checks in EDC systems.
Lead User Acceptance Testing (UAT) tasks for complex studies and modules.
Coordinate with Sponsor and Vendors for efficient electronic data receipt, integration, and reconciliation.
Troubleshoot technical issues and design effective data review processes.
Manage queries and trends to ensure data completeness and integrity.
Perform coding of adverse events, medical conditions, and medications.
Lead pre-lock and data lock tasks.
Prepare training materials and user guides for EDC data collection tools.
Provide study-specific training for team members and end users.
Implement technical solutions and resolve complex issues.
Provide regular status updates to cross-functional study teams, management, and sponsors.
Ensure archiving of study databases and related documents.
Organize and file study documentation.
Provide input to cross-functional study timelines and resource requirements.
Present at sales and marketing meetings for prospective clients.
Assist with identification of project scope changes.

Requirements: