Job Description

Role Description

The Senior Director, Global Clinical Data Management will provide strategic and operational leadership for all clinical trial data management activities across the global development portfolio. This role ensures delivery of high-quality, regulatory-compliant clinical datasets to support submissions, publications, and decision-making. The Senior Director will define enterprise-wide clinical data governance strategy and ensure consistent, high-quality data across clinical development, real-world evidence, and digital health programs.

Essential Functions

• Define and execute global Clinical Data Management (CDM) strategy across Phase I–IV clinical trials.
• 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 to ensure strong succession planning and talent retention.
• Responsible for indirectly leading a team of Clinical Data Management Leaders in the planning, directing, and coordinating of all Clinical Data operations across the global segment.
• Own talent management processes at the leadership level.
• 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 (CROs, FSPs, external partners) ensuring delivery on time, within budget, and to quality standards.
• Oversee data quality, lineage, traceability, and audit readiness systems.
• Drive inspection readiness and regulatory audit support for clinical datasets.
• Lead modernization initiatives including automation, AI-enabled data review, and advanced clinical data platforms.
• Oversee Clinical Data Management budget planning, resource forecasting, and vendor contracts.
• Build and manage a high-performing Clinical Data Management team through hiring, developing, and providing performance feedback to subordinate managerial and professional talent.
• Collaborate within and across functional areas to evaluate, recommend, and implement process and technology improvement initiatives.
• Ensure compliance with GCP, SOPs, and regulatory expectations.
• Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Qualifications

• 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 of direct and indirect reports required.
• Experience managing a global team strongly preferred.

Knowledge, Skills, & Abilities

• Deep knowledge of EDC systems, CDMS platforms, SDTM/CDISC standards.
• Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
• Strong regulatory inspection experience (FDA/EMA).
• Strong enterprise data governance experience.
• Expertise in multi-study portfolio management.
• Ability to understand and interpret clinical data analytics and analyze outcomes.
• Excellent leadership skills with the ability to build a high-performing team and lead others effectively.
• Excellent project management skills with the ability to prioritize multiple tasks and objectives to consistently deliver to goals and timelines.
• Strong critical and logical thinking with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.

Working Environment / Physical Environment

• This position works on-site or remotely depending on the candidate’s geographic location as noted in your offer letter.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• This position works in an office environment and requires regular use of computer keyboards and sitting for extended periods of time.

Compensation

• National Market: $230,000 (entry-level qualifications) to $253,000 (highly experienced) annually.
• Premium Market: $260,000 (entry-level qualifications) to $280,000 (highly experienced) annually.

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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