Director, Clinical Data Management
Director, Clinical Data Management
L7
Industries
Research and Development in BiotechnologyResearch and Development in the Physical, Engineering, and Life SciencesPharmaceutical Preparation Manufacturing- Lead, coach, and mentor managers and data managers, providing performance feedback and growth opportunities
- Oversee portfolio-level execution, tracking milestones and deliverables, and resolving risks and critical issues
- Partner with senior leadership to shape department goals, organizational structure, and resource allocation
- Hold CROs and vendors accountable for quality and compliance, and help build long-term outsourcing partnerships
- Drive inspection and audit readiness, overseeing the team through inspections and quality gap resolution
- Build strong relationships across teams by negotiating effectively, managing conflict, and collaborating
- Sponsor or lead cross-functional initiatives and represent Data Management in program and leadership forums This role requires:
- Bachelor's degree in Mathematics, Science, or a related field, plus a Certified Clinical Data Manager (CCDM) certification
- 12+ years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry
- 5+ years of people management experience
- Expert knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards
- Proven record of leading studies and study teams, and of motivating virtual teams in a matrix environment
- Strong problem-solving, project management, and communication skills, with a strategic approach and the ability to thrive in a fast-paced environment
Level
ManagerL7
Location
Somerville, MA
Occupation
Medical and Health Services Managers
Industry
Research and Development in Biotechnology
Posted
3 days ago
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