Responsibilities :
- Manage Data Management tasks from study start-up to database lock for assigned studies.
- Lead multiple large and complex studies, delegating tasks as needed.
- Interact effectively with sponsors and oversee vendors.
- Mentor junior personnel.
- Develop SOPs and study-specific procedures.
- Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents.
- 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.
- Assist with identification of project scope changes.
- Present at sales and marketing meetings for prospective clients.
- Develop SOPs and manuals.
Requirements :
- Minimum BS in a scientific or health-related field or equivalent.
- Minimum years of experience in Clinical Data Management.
- Knowledge of medical terminology and pharmaceutical notation.
- Expertise with EDC systems such as Medidata Rave, InForm, Medrio.
- Excellent organizational and time management skills.
- Strong collaboration and leadership skills.
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