Note: The job is a remote job and is open to candidates in USA. Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric disorders. The Director of Clinical Data Management will oversee CDM operations, ensuring high data quality and regulatory compliance while leading a team and collaborating cross-functionally.
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
Skills
- 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
- Experience with data visualization tools (e.g., Elluminate)
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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