Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Organizational Overview:
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
The Role:
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.
Key Responsibilities:
Leadership & Management
- 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 (but do not directly own) the data management operations team and vendors, ensuring systems strategy aligns with DM process needs.
Clinical Systems Strategy & Governance
- Own the enterprise strategy, roadmap, and governance model for core clinical data systems, including:
- eCOA / ePRO platforms (patient/clinician-reported outcomes)
- eDiary systems
- Medidata Rave EDC
- Elluminate (data review, aggregation, and analytics platform)
- 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, including SLA definition, performance monitoring, and renewal/negotiation strategy.
- Own system-related budget planning, licensing decisions, and total cost of ownership analysis.
System Implementation & Lifecycle Management
- Lead selection, evaluation, and implementation of new clinical systems and platform upgrades, including RFP processes and vendor due diligence.
- Oversee computer system validation (CSV/CSA) activities, ensuring systems meet 21 CFR Part 11, GxP, and data integrity requirements.
- Direct system configuration, build, and testing activities for EDC, eCOA, eDiary, and Elluminate environments.
- Manage the end-to-end lifecycle of clinical systems: onboarding, ongoing maintenance, periodic review, upgrades, and decommissioning/retirement/data archival.
- Establish and maintain disaster recovery, business continuity, and system uptime/performance standards in partnership with IT.
Integration & Interoperability
- Lead architecture and oversight of system integrations (e.g., EDC-to-eCOA, EDC-to-Elluminate, EDC-to-IRT/RTSM/safety databases) to ensure seamless, accurate, and timely 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, distinguishing systems-level root causes from data management process issues.
- Drive adoption of automation, AI-enabled tools, and dashboarding/analytics capabilities to improve data flow visibility and reduce manual effort.
Compliance, Quality & Risk
- Ensure clinical systems remain inspection-ready at all times; serve as the systems SME during regulatory inspections and audits.
- Maintain SOPs, validation documentation, and system-level quality standards in partnership with Quality Assurance.
- Monitor emerging regulatory guidance (e.g., FDA, EMA, ICH E6(R3)) related to clinical technology and data integrity, and proactively adapt systems strategy accordingly.
- Own risk assessments related to system changes, upgrades, and vendor transitions.
Cross-Functional Collaboration
- Serve as the primary systems liaison to 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 at the program level.
- Educate and train clinical data management and cross functional staff on system capabilities, updates, and best practices.
Required 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) — this role oversees systems, not day-to-day data management operations, but requires fluency in DM processes to inform systems decisions.
- 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
- 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.
Preferred Qualifications
- Experience across multiple therapeutic areas and trial phases (I–IV).
- Familiarity with additional clinical technologies (e.g., IRT/RTSM, CTMS, safety databases, eTMF).
- Experience with system integration architecture, APIs, and data pipeline/interface design.
- Certification in clinical data management (e.g., CCDM), IT/systems (e.g., ITIL), or project management (e.g., PMP).
- Experience with computer system validation methodologies and audit trail/data integrity frameworks.
Skills & Competencies
- Strategic, technology-forward thinking paired with strong operational execution.
- Deep understanding of clinical data management principles, applied through a systems and governance lens.
- Excellent people leadership, coaching, and team-building skills.
- Strong vendor management, negotiation, and contract oversight capabilities.
- Ability to translate business/process needs into scalable technical solutions.
- Excellent written and verbal communication skills, including with technical and non-technical stakeholders.
- Comfortable operating in a fast-paced, matrixed organization.
Work Environment:
- Remote-based
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (10-20%)
Salary range for posting$260,000—$290,000 USD
Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.
Poland
Colombia