Senior Director, Global Clinical Data Management
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Job Description
Senior Director overseeing clinical trial data management strategies in a biotechnology company. Responsible for ensuring high-quality data and compliance across clinical development and digital health programs.
Responsibilities:
- Provide strategic and operational leadership for all clinical trial data management activities across the global development portfolio
- Ensure delivery of high-quality, regulatory-compliant clinical datasets to support submissions, publications, and decision-making
- Define enterprise-wide clinical data governance strategy and ensure consistent, high-quality data across clinical development, real-world evidence, and digital health programs
- Lead end-to-end data management operations including CRF design, database build, edit check strategy, and database lock
- Responsible for the oversight of the Clinical Data Management team
- Lead and mentor the leadership team in the development and improvement of skills, knowledge and abilities
- Ensure effective quality, efficiency, and timeliness of data management projects through appropriate resource allocation and work prioritization
- Establish global data standards, governance frameworks, and quality systems aligned with GCP, FDA, EMA, and ICH guidelines
- Oversee clinical data vendors ensuring delivery on time, within budget, and to quality standards
- Drive inspection readiness and regulatory audit support for clinical datasets
- Collaborate within and across functional areas to evaluate, recommend, and implement process and technology improvement initiatives
Requirements:
- Bachelor’s or Master’s degree in life sciences or technical discipline required
- 12+ years of clinical data, clinical operations, or healthcare data systems experience required
- Strong enterprise data governance experience required
- Experience developing and managing a team direct and indirect reports required
- Experience managing a global team strongly preferred
- Deep knowledge of EDC systems, CDMS platforms, SDTM/CDISC standards
- Working knowledge of the clinical research, Good Clinical Practices, and regulatory requirements/guidelines
- Strong regulatory inspection experience (FDA/EMA)
- Expertise in multi-study portfolio management
- Ability to understand, and interpret clinical data analytics and analyze outcomes
- Excellent project management skills with the ability to prioritize multiple tasks and objectives to consistently deliver to goals and timelines
Benefits:
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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