Senior Director, Global Clinical Data Management

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

📋 Description

• Provide strategic and operational oversight for all activities related to clinical trial data management across the global development portfolio.

• Ensure the delivery of high-quality, regulatory-compliant clinical datasets to support submissions, publications, and informed decision-making.

• Define a comprehensive clinical data governance strategy that ensures consistent, high-quality data across clinical development, real-world evidence, and digital health initiatives.

• Lead the complete data management operations, encompassing CRF design, database construction, edit check strategy, and database locking.

• Oversee the Clinical Data Management team, ensuring effective leadership and guidance.

• Mentor the leadership team to enhance their skills, knowledge, and capabilities.

• Guarantee the quality, efficiency, and timeliness of data management projects through appropriate resource allocation and prioritization of tasks.

• Establish global data standards, governance frameworks, and quality systems in alignment with GCP, FDA, EMA, and ICH guidelines.

• Manage clinical data vendors to ensure timely delivery, adherence to budget, and compliance with quality standards.

• Drive readiness for inspections and provide support for regulatory audits concerning clinical datasets.

• Collaborate across functional areas to assess, recommend, and implement initiatives for process and technology improvements.

⛳️ Requirements

• A Bachelor’s or Master’s degree in life sciences or a technical discipline is required.

• A minimum of 12 years of experience in clinical data, clinical operations, or healthcare data systems is required.

• Strong experience in enterprise data governance is required.

• Proven experience in developing and managing a team of direct and indirect reports is required.

• Experience managing a global team is strongly preferred.

• Extensive knowledge of EDC systems, CDMS platforms, and SDTM/CDISC standards is essential.

• Familiarity with clinical research, Good Clinical Practices, and regulatory requirements/guidelines is necessary.

• Significant regulatory inspection experience (FDA/EMA) is required.

• Expertise in managing a multi-study portfolio is essential.

• Ability to understand and interpret clinical data analytics and analyze outcomes is necessary.

• Excellent project management skills with the capability to prioritize multiple tasks and objectives to consistently meet goals and deadlines.

🏝️ 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.