Senior Director, Data Management Systems

Role Description

Reporting to the Vice President, Data Management, this position is responsible for providing strategic and operational leadership over the clinical data technology ecosystem, including eCOA/ePRO platforms, eDiary solutions, Medidata Rave (EDC), and Elluminate. This role is not directly responsible for hands-on clinical data management activities (e.g., data cleaning, query resolution, database lock); rather, it requires a strong clinical data management background to inform sound systems strategy, oversee system governance, and lead a team responsible for platform architecture, configuration, integration, and lifecycle management. The ideal candidate understands data management processes deeply enough to translate them into scalable, well-governed technology solutions, and brings proven experience leading systems teams. Serves as a key member of the Data Management Leadership Team, supporting cross-functional team needs and oversees the management of system related enhancements to support study deliverables. Interfaces with CROs and is responsible for managing internal Data Management team members.

Qualifications

• Bachelor's degree in life sciences, health information, computer science, or related field (advanced degree preferred).
• 15+ years of progressive experience in clinical data management and/or clinical data systems within pharmaceutical, biotech, or CRO environments.
• Strong foundational background in clinical data management (data cleaning, query management, database lock, DM planning).
• 5+ years of people management experience, including managing managers or system-focused teams.
• Demonstrated experience owning or administering eCOA/ePRO systems, eDiary platforms, Medidata Rave EDC, and Elluminate.
• Strong knowledge of system validation (CSV/CSA), 21 CFR Part 11, ICH-GCP, and global regulatory requirements governing clinical data systems.
• Proven track record leading system implementations, upgrades, integrations, and vendor management.
• Experience supporting regulatory inspections and audits related to clinical systems and data integrity.

Requirements

• Lead, mentor, and develop a team of clinical trial solutions personnel.
• Set systems strategy, roadmap, and performance metrics; conduct performance reviews and support career development.
• Manage systems related budget, resourcing, vendor contracts, and staffing plans across concurrent systems and study portfolios.
• Serve as a key member of the clinical data management leadership team, representing clinical systems in cross-functional governance forums.
• Partner with the data management operations team and vendors, ensuring systems strategy aligns with DM process needs.
• Own the enterprise strategy, roadmap, and governance model for core clinical data systems.
• Define and maintain system governance frameworks: access management, role-based permissions, change control, and version control across platforms.
• Establish standards for system configuration, study build templates, and reusable libraries to drive consistency and efficiency across studies.
• Lead vendor management and contract oversight for all clinical systems vendors.
• Own system-related budget planning, licensing decisions, and total cost of ownership analysis.
• Lead selection, evaluation, and implementation of new clinical systems and platform upgrades.
• Oversee computer system validation (CSV/CSA) activities.
• Direct system configuration, build, and testing activities for EDC, eCOA, eDiary, and Elluminate environments.
• Manage the end-to-end lifecycle of clinical systems.
• Establish and maintain disaster recovery, business continuity, and system uptime/performance standards in partnership with IT.
• Lead architecture and oversight of system integrations to ensure seamless data flow.
• Partner with IT/technical teams to define data integration specifications, API/interface requirements, and data mapping standards.
• Troubleshoot and resolve systemic/integration-level issues.
• Drive adoption of automation, AI-enabled tools, and dashboarding/analytics capabilities.
• Ensure clinical systems remain inspection-ready at all times.
• Maintain SOPs, validation documentation, and system-level quality standards in partnership with Quality Assurance.
• Monitor emerging regulatory guidance related to clinical technology and data integrity.
• Own risk assessments related to system changes, upgrades, and vendor transitions.
• Serve as the primary systems liaison to various departments.
• Provide systems and technology input into protocol development, study design feasibility, and technology selection.
• Educate and train clinical data management and cross-functional staff on system capabilities, updates, and best practices.

Benefits

• Salary range: $260,000 — $290,000 USD.
• Compensation based on market location and job-related knowledge, skills, and experience.
• Equity and other forms of compensation may be provided as part of a total compensation package.
• Full range of medical, dental, vision, 401k, and other benefits.
• Unlimited paid time off and parental leave.

Work Environment

• Remote-based.
• Dynamic, interactive, fast-paced, and entrepreneurial environment.
• Domestic or international travel required (10-20%).