Senior Director, Data Management Systems

<div class="content-intro"><p>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.</p></div><p><strong>Organizational Overview:</strong></p>

<p>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.</p>

<p><strong>The Role:</strong></p>

<p>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.</p>

<p><strong>Key Responsibilities: </strong></p>

<p> <strong>Leadership & Management</strong></p>

<ul>

<li>Lead, mentor, and develop a team of clinical trial solutions personnel</li>

<li>Set systems strategy, roadmap, and performance metrics; conduct performance reviews and support career development.</li>

<li>Manage systems related budget, resourcing, vendor contracts, and staffing plans across concurrent systems and study portfolios.</li>

<li>Serve as a key member of the clinical data management leadership team, representing clinical systems in cross-functional governance forums.</li>

<li>Partner with (but do not directly own) the data management operations team and vendors, ensuring systems strategy aligns with DM process needs.</li>

</ul>

<p><strong>Clinical Systems Strategy & Governance</strong></p>

<ul>

<li>Own the enterprise strategy, roadmap, and governance model for core clinical data systems, including:</li>

<ul>

<li><strong>eCOA / ePRO platforms</strong> (patient/clinician-reported outcomes)</li>

<li><strong>eDiary systems</strong></li>

<li><strong>Medidata Rave EDC</strong></li>

<li><strong>Elluminate</strong> (data review, aggregation, and analytics platform)</li>

</ul>

<li>Define and maintain system governance frameworks: access management, role-based permissions, change control, and version control across platforms.</li>

<li>Establish standards for system configuration, study build templates, and reusable libraries to drive consistency and efficiency across studies.</li>

<li>Lead vendor management and contract oversight for all clinical systems vendors, including SLA definition, performance monitoring, and renewal/negotiation strategy.</li>

<li>Own system-related budget planning, licensing decisions, and total cost of ownership analysis.</li>

</ul>

<p><strong>System Implementation & Lifecycle Management</strong></p>

<ul>

<li>Lead selection, evaluation, and implementation of new clinical systems and platform upgrades, including RFP processes and vendor due diligence.</li>

<li>Oversee computer system validation (CSV/CSA) activities, ensuring systems meet 21 CFR Part 11, GxP, and data integrity requirements.</li>

<li>Direct system configuration, build, and testing activities for EDC, eCOA, eDiary, and Elluminate environments.</li>

<li>Manage the end-to-end lifecycle of clinical systems: onboarding, ongoing maintenance, periodic review, upgrades, and decommissioning/retirement/data archival.</li>

<li>Establish and maintain disaster recovery, business continuity, and system uptime/performance standards in partnership with IT.</li>

</ul>

<p><strong>Integration & Interoperability</strong></p>

<ul>

<li>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.</li>

<li>Partner with IT/technical teams to define data integration specifications, API/interface requirements, and data mapping standards.</li>

<li>Troubleshoot and resolve systemic/integration-level issues, distinguishing systems-level root causes from data management process issues.</li>

<li>Drive adoption of automation, AI-enabled tools, and dashboarding/analytics capabilities to improve data flow visibility and reduce manual effort.</li>

</ul>

<p><strong>Compliance, Quality & Risk</strong></p>

<ul>

<li>Ensure clinical systems remain inspection-ready at all times; serve as the systems SME during regulatory inspections and audits.</li>

<li>Maintain SOPs, validation documentation, and system-level quality standards in partnership with Quality Assurance.</li>

<li>Monitor emerging regulatory guidance (e.g., FDA, EMA, ICH E6(R3)) related to clinical technology and data integrity, and proactively adapt systems strategy accordingly.</li>

<li>Own risk assessments related to system changes, upgrades, and vendor transitions.</li>

</ul>

<p><strong>Cross-Functional Collaboration</strong></p>

<ul>

<li>Serve as the primary systems liaison to Clinical Data Management, Biostatistics, Clinical Operations, Clinical Development, Regulatory, Quality, and IT.</li>

<li>Provide systems and technology input into protocol development, study design feasibility, and technology selection at the program level.</li>

<li>Educate and train clinical data management and cross functional staff on system capabilities, updates, and best practices.</li>

</ul>

<p><strong>Required Qualifications</strong></p>

<ul>

<li>Bachelor's degree in life sciences, health information, computer science, or related field (advanced degree preferred).</li>

<li>15+ years of progressive experience in clinical data management and/or clinical data systems within pharmaceutical, biotech, or CRO environments.</li>

<li>Strong foundational background in <strong>clinical data management</strong> (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.</li>

<li>5+ years of people management experience, including managing managers or system-focused teams.</li>

<li>Demonstrated experience owning or administering:</li>

<ul>

<li><strong>eCOA/ePRO systems</strong></li>

<li><strong>eDiary platforms</strong></li>

<li><strong>Medidata Rave EDC</strong></li>

<li><strong>Elluminate</strong></li>

</ul>

<li>Strong knowledge of system validation (CSV/CSA), 21 CFR Part 11, ICH-GCP, and global regulatory requirements governing clinical data systems.</li>

<li>Proven track record leading system implementations, upgrades, integrations, and vendor management.</li>

<li>Experience supporting regulatory inspections and audits related to clinical systems and data integrity.</li>

</ul>

<p><strong>Preferred Qualifications</strong></p>

<ul>

<li>Experience across multiple therapeutic areas and trial phases (I–IV).</li>

<li>Familiarity with additional clinical technologies (e.g., IRT/RTSM, CTMS, safety databases, eTMF).</li>

<li>Experience with system integration architecture, APIs, and data pipeline/interface design.</li>

<li>Certification in clinical data management (e.g., CCDM), IT/systems (e.g., ITIL), or project management (e.g., PMP).</li>

<li>Experience with computer system validation methodologies and audit trail/data integrity frameworks.</li>

</ul>

<p><strong>Skills & Competencies</strong></p>

<ul>

<li>Strategic, technology-forward thinking paired with strong operational execution.</li>

<li>Deep understanding of clinical data management principles, applied through a systems and governance lens.</li>

<li>Excellent people leadership, coaching, and team-building skills.</li>

<li>Strong vendor management, negotiation, and contract oversight capabilities.</li>

<li>Ability to translate business/process needs into scalable technical solutions.</li>

<li>Excellent written and verbal communication skills, including with technical and non-technical stakeholders.</li>

<li>Comfortable operating in a fast-paced, matrixed organization.</li>

</ul>

<p><strong>Work Environment:</strong></p>

<ul>

<li>Remote-based</li>

<li>Dynamic, interactive, fast-paced, and entrepreneurial environment</li>

<li>Domestic or international travel are required (10-20%)</li>

</ul>

<p> </p>

<p> </p>

<p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Salary range for posting</div><div class="pay-range"><span>$260,000</span><span class="divider">—</span><span>$290,000 USD</span></div></div></div><div class="content-conclusion"><p>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.</p>

<p> </p></div>