Director, Clinical Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage CDM operations encompassing CRF/eCRF design, validation programming, discrepancy management, and database development/production.

• Supervise CROs, vendors, and internal teams to uphold quality standards and performance metrics.

• Ensure that CDM documentation, SOPs, and processes facilitate high data quality, integrity, and regulatory compliance with FDA, GCP, ICH, and GCDMP standards.

• Collaborate within Biometrics and Data Science as well as across functions on data management challenges and alignment.

• Recruit, nurture, inspire, and provide leadership to CDM staff and consultants.

• Assist in resource planning, budget forecasting, timelines, and resolving issues for ongoing clinical trials.

• Identify risks and challenges in clinical trial data management and suggest solutions to uphold timelines and quality.

• Elevate strategic, budgetary, or cross-functional issues when broader leadership input is needed.

• Capable of meeting deadlines, prioritizing workload, and managing multiple priorities at once.

• Familiarity with data visualization tools (e.g., Elluminate) is preferred.

• Must maintain an inspection-ready environment and support regulatory preparedness.

• Willingness to travel as required.

⛳️ Requirements

• Bachelor’s or Master’s degree in a relevant scientific field.

• At least 8 years of CDM experience within a pharmaceutical, biotech, or CRO environment.

• Minimum of 4 years in a line management role.

• Global or international experience is essential.

• Strong background in cross-functional leadership, clinical trial execution, vendor oversight, and inspection readiness.

• Advanced knowledge of CDM processes, EDC systems, database programming, quality management, and technology trends.

• Comprehensive understanding of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines.

• Excellent leadership, mentoring, recruitment, and team development capabilities.

• Outstanding communication, interpersonal, influencing, and negotiation skills.

• Proficient problem-solving, analytical thinking, prioritization, and organizational abilities.

• Ability to juggle multiple priorities, adapt to evolving business needs, and collaborate effectively across functions.

🏝️ Benefits

• Comprehensive health benefits coverage including Medical, Dental, and Vision for you and your dependents.

• 401(k) plan with company matching and vesting commencing after the first month following your start date.

• Flexible time off policy.

• Generous parental leave along with some enjoyable fringe benefits!