Clinical Data Manager

Katalyst Healthcares & Life Sciences • New Haven, CT, United States • $200k - $250k / year • 1w ago

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 10 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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