Job Description

• 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:

• Minimum BS in a scientific or health-related field or equivalent.
• Minimum 9+ years of experience in Clinical Data Management.
• Knowledge of medical terminology and pharmaceutical notation.
• Expertise with EDC systems such as Medidata Rave, InForm, Medrio.
• Strong collaboration and leadership skills.
• Excellent organizational and time management skills.

Job Tags

Similar Jobs