[Hiring] Senior Director, Data Management Systems @IMVT Corporation

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%).