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Duties
- Primary DM contact for projects
- Oversee project data entry process
- Perform quality control of data entry
- Develop CRF specifications
- Assist in building clinical databases
- Conduct database build UAT
- Oversee database quality
- Specify edit check requirements
- Maintain data management documentation
- Train clinical research personnel
- Review and query clinical trial data
- Perform line listing data review
- Run patient and study level reporting
- Perform medical coding
- Coordinate SAE/AE reconciliation
- Liaise with third-party vendors
- Assist with SAS programming
- Identify and troubleshoot issues
- Review protocols and CSRs
- Develop and maintain SOPs
- Attend strategy and bid meetings
- Review RFPs and proposals
- Provide leadership for initiatives
- Ensure team training
- Communicate with sponsors and teams
- Present software demonstrations
- Travel as needed
- Perform other duties as assigned
Requirements
- Bachelors or related experience
- Lead Data Manager experience
- Proficient in Microsoft Office
- Handle clinical research tasks
- Excellent organizational skills
- Professional English use
- Experience with clinical databases
- Knowledge of drug development
- Strong communication skills
- Leadership and interpersonal skills
- Ability to travel
Benefits
- Equal Opportunity Employer
- No discrimination in employment decisions
