Manager, Clinical Data Management

Direct Hire Full-Time Role

Salary Range: $154,000 - $175,000 per year

Location: Boston, MA - Hybrid or Remote

Duties and Responsibilities:

• Oversee a team of Clinical Data Managers.
• Manage each project assigned to the team.
• Perform quality control for each deliverable before sending to internal or external clients.
• Prepare and present individual performance reviews.
• Mentor staff and suggest and implement solutions for complex issues.
• Assist staff with interactions with sponsors and managing vendors.
• Keep supervisors updated on study progress and staff management through routine meetings.
• Maintain a positive, progressive, and proactive management style and communication.
• Develop and update data management SOPs and training manuals
• Conduct data management training and study-specific training for the CDM and study teams.
• Provide input from the data management perspective regarding the design of clinical trial protocols.
• Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
• Oversee and participate in the process of data review and query generation procedures.
• Participate in the coding of medical terms.
• Define and perform SAE reconciliation processes.
• Work with DM leads and database programmers to design (e)CRFs and edit checks in the EDC system.
• Ensure proper completion of UAT of EDC system and modules.
• Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation.
• Review queries and trends to ensure data completeness and integrity.
• Prepare training materials and user guides for EDC data collection tools and deliver user training.
• Participate in client and team meetings as required, advising on best practices as appropriate.
• 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.
• Implement technical solutions, new tools, and process improvement strategies.
• Lead large and complex projects and identify project scope changes when necessary.
• Present at sales and marketing meetings for prospective clients.
• Provide strategic input to the department and company goals.
• Lead key departmental goals and initiatives.

Requirements and Qualifications:

• 10 years of experience in Clinical Data Management
• Minimum of 2 years of supervisory experience is required
• BS in a scientific or health-related field
• Knowledge of GCPs and regulatory agency guidelines
• Familiarity with medical terminology
• Skilled in the use of data management software application Medidata RAVE
• Excellent organizational and time management skills
• Strong collaboration and leadership skills
• Excellent oral and written communication skills
• Strong interpersonal skills

Desired Skills and Experience

Clinical Data Management, GCPs, regulatory, Medidata RAVE

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