Director, Clinical Data Management
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Job Description
Director overseeing Clinical Data Management at Definium Therapeutics, a biopharmaceutical firm. Leading CDM operations and ensuring compliance with FDA and regulatory standards.
Responsibilities:
- Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production
- Provide oversight of CROs, vendors, and internal teams to maintain quality standards and performance metrics
- Ensure CDM documentation, SOPs, and processes support high data quality, integrity, and regulatory compliance with FDA, GCP, ICH, and GCDMP requirements
- Partner within Biometrics and Data Science as well as cross-functionally on data management issues and alignment
- Recruit, develop, motivate, and provide leadership to CDM staff and consultants
- Support resource planning, budget forecasting, timelines, and issue resolution for ongoing clinical trials
- Identify risks and challenges in clinical trial data management and propose solutions to maintain timelines and quality
- Escalate strategic, budgetary, or cross-functional issues when broader leadership input is required
- Ability to meet deadlines, prioritize workload, and handle multiple priorities simultaneously
- Experience with data visualization tools (e.g., Elluminate) (preferred)
- Must maintain an inspection-ready environment and support regulatory readiness
- Willingness to travel as needed
Requirements:
- Bachelor’s or Master’s degree in a scientific subject area
- Minimum of 8 years CDM experience in a pharmaceutical, biotech or CRO setting
- At least 4 years of line management experience
- Global or international experience is required
- Strong experience in cross functional leadership, clinical trial execution, vendor oversight, and inspection readiness
- Sophisticated knowledge of CDM processes, EDC systems, database programming, quality management and technology trends
- In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines
- Strong leadership, mentoring, recruiting and team development skills
- Excellent communication, interpersonal, influencing and negotiation skills
- Strong problem-solving, analytical thinking, prioritization and organizational skills
- Ability to manage multiple priorities, adapt to changing business needs, and work collaboratively across functions
Benefits:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
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