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

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

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!

Director, Clinical Data Management

Key skills