IntePros
Clinical Data Management Leadership Opportunity
Location: Cambridge, MA | Type: Full-Time | Industry: Clinical Research / CRO
Our client, a full-service clinical research organization (CRO), is seeking an experienced Clinical Data Management professional to join their team in a leadership capacity. This organization supports biopharmaceutical and medical device companies of all sizes and is known for its collaborative, mission-driven culture focused on improving patient lives through clinical innovation.
We're partnering with them to identify a dynamic individual to lead a team of Clinical Data Managers across multiple projects. This is an excellent opportunity for someone with a strong background in data management and a passion for mentoring, strategy, and process improvement.
Key Responsibilities
Lead, manage, and mentor a team of Clinical Data Managers (CDMs)
Oversee project execution, ensuring quality and timely deliverables
Conduct quality control of team outputs before delivery to internal or external stakeholders
Perform staff evaluations and provide ongoing professional development
Support interactions with sponsors and vendors as needed
Maintain regular communication with leadership on study progress and team management
Develop and refine SOPs, training manuals, and study-specific documentation
Lead training efforts for team members and study teams
Provide strategic input on clinical protocol design from a data management perspective
Manage documentation such as DMPs, eCRF specifications, CRF Completion Guidelines, edit checks, and coding guidelines
Oversee coding of medical terms and SAE reconciliation processes
Ensure proper execution of UAT and EDC build/testing with internal and external teams
Contribute to system training and develop user guides for EDC tools
Lead complex studies and drive process improvement initiatives
Participate in client meetings and sales presentations as a subject matter expert
Contribute to departmental goals and cross-functional planning
Qualifications
Education:
Bachelor's degree in a scientific or health-related field (or equivalent experience)
Experience:
Minimum of 10 years of Clinical Data Management experience
At least 2 years of direct supervisory experience
Skills:
Strong understanding of GCPs and regulatory guidelines
Familiarity with medical terminology
Proficient in industry-standard data management systems (e.g., Medidata RAVE)
Proven leadership and team-building skills
Excellent communication, time management, and organizational abilities
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