Senior Director, Data Management Systems

Immunovant

Senior Director leading clinical data systems for Immunovant’s autoimmune disease therapies. Overseeing platforms, governance, integrations, vendors, compliance, and clinical technology teams.

Posted 8/19/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $260,000 - $290,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in clinical data management, including system validation, eCOA/ePRO platforms, and regulatory compliance, while effectively leading teams and managing vendor relationships to ensure operational excellence.

Highest-signal resume keywords

Clinical Data ManagementECOA/ePRO Systems AdministrationSystem Validation (CSV/CSA)Vendor ManagementRegulatory Compliance (21 CFR Part 11, ICH-GCP)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data CleaningQuery ManagementDatabase LockDM PlanningSystem Integration ArchitectureAPI DesignData MappingClinical Systems Lifecycle ManagementAutomation ToolsDashboarding/Analytics

Soft Skills

LeadershipStrategic ThinkingOperational ExecutionNegotiationCommunication

Tools & Technologies

Medidata Rave EDCElluminateEDiary SystemsIRT/RTSMCTMSSafety DatabasesETMF

Certifications & Qualifications

Clinical Data Management CertificationIT/Systems CertificationProject Management Certification

Industry Keywords

PharmaceuticalBiotechCROGxPFDAEMAICH E6(R3)Clinical Trial Phases (I–IV)

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide strategic and operational leadership over the clinical data technology ecosystem
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
Represent clinical systems in cross-functional governance forums
Own enterprise strategy, roadmap, and governance for eCOA/ePRO platforms, eDiary systems, Medidata Rave EDC, and Elluminate
Define governance frameworks for access management, role-based permissions, change control, and version control
Establish system configuration standards, study build templates, and reusable libraries
Lead vendor management, contract oversight, SLA definition, performance monitoring, and renewal/negotiation strategy
Lead selection, evaluation, implementation, and upgrades of clinical systems, including RFPs and vendor due diligence
Oversee computer system validation activities and compliance with 21 CFR Part 11, GxP, and data integrity requirements
Direct system configuration, build, and testing for EDC, eCOA, eDiary, and Elluminate environments
Manage the full clinical systems lifecycle, including onboarding, maintenance, reviews, upgrades, retirement, and data archival
Establish disaster recovery, business continuity, and uptime/performance standards with IT
Lead architecture and oversight of integrations between clinical systems
Define integration specifications, API/interface requirements, and data mapping standards with technical teams
Troubleshoot systemic and integration-level issues
Drive automation, AI-enabled tools, and dashboarding/analytics to improve data visibility and reduce manual effort
Keep clinical systems inspection-ready and serve as systems SME during regulatory inspections and audits
Maintain SOPs, validation documentation, and system-level quality standards with Quality Assurance
Monitor FDA, EMA, and ICH E6(R3) guidance and adapt systems strategy
Own risk assessments for system changes, upgrades, and vendor transitions
Liaise with Clinical Data Management, Biostatistics, Clinical Operations, Clinical Development, Regulatory, Quality, and IT
Provide systems and technology input into protocol development, study design feasibility, and technology selection
Educate and train staff on system capabilities, updates, and best practices
Report to the Vice President, Data Management
Interface with CROs and manage internal Data Management team members

Requirements

What you’ll need

Bachelor's degree in life sciences, health information, computer science, or related field
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, including data cleaning, query management, database lock, and 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
Experience across multiple therapeutic areas and trial phases (I–IV) preferred
Familiarity with additional clinical technologies such as IRT/RTSM, CTMS, safety databases, and eTMF preferred
Experience with system integration architecture, APIs, and data pipeline/interface design preferred
Certification in clinical data management, IT/systems, or project management preferred
Experience with computer system validation methodologies and audit trail/data integrity frameworks preferred
Strategic, technology-forward thinking paired with strong operational execution
Deep understanding of clinical data management principles applied through a systems and governance lens
Strong vendor management, negotiation, and contract oversight capabilities
Ability to translate business/process needs into scalable technical solutions
Comfortable operating in a fast-paced, matrixed organization

Benefits

Comp & perks

Equity and other forms of compensation may be provided as part of a total compensation package
Medical benefits
Dental benefits
Vision benefits
401(k)
Unlimited paid time off
Parental leave
Domestic or international travel opportunities (10–20%)