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
#LI-DR2