Clinical Data Manager

Clinical Data Manager

Direct Hire Full-Time Role

Salary Range : $130,000 - $150,000 per year

Location : Boston, MA - Hybrid or Remote

Duties and Responsibilities :

• You will develop and maintain study-specific documentation and manage clinical data.
• Create Data Management Plans, eCRF specifications, CRF Completion Guidelines, and Data Validation Guidelines.
• Produce Data Transfer Specifications, Coding Guidelines, a Post-Production Database, Change Control Documentation, Database Audits, and Lock Procedures.
• Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules.
• Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming.
• Work with database programmers to design (e)CRFs and edit checks in the EDC system for complex studies.
• Coordinate with Sponsors and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation.
• Troubleshoot technical issues.
• Design listings and study-specific processes for effective data review, query issues, and resolution.
• Manage queries and trends to ensure data completeness and integrity.
• Perform coding of adverse events, medical conditions, and medications.
• Perform SAE reconciliation.
• Lead and perform pre-lock and data lock tasks.
• Prepare training materials and user guides for EDC data collection tools; deliver user training.
• Participate in client and team meetings as required, providing status updates and advising on best practices as appropriate.
• Design, generate, and review status metric reports, identifying and communicating trends as needed.
• Ensure the archival of study databases and related documents.
• Organize and file study documentation.
• Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies.
• Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes.
• Provide study-specific training for team members and end users.
• Implement technical solutions and new tools and resolve complex issues.
• Lead large and complex projects.
• Lead client and team meetings as required.
• Delegate tasks as appropriate, providing mentorship and following through completion.
• Interact with sponsors and manage vendors for complex studies.
• Assist with the identification of project scope changes.
• Present at sales and marketing meetings for prospective clients.
• Develop SOPs and manuals.

Requirements and Qualifications :

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

Desired Skills and Experience

Clinical Data Management, eCRF, UAT, EDC, Medidata Rave, InForm, Medrio

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