Senior Director, Data Management Systems
Immunovant
August 19, 2026
Remote
United States
IT
Role
- Provide strategic and operational leadership for the clinical data technology ecosystem (eCOA/ePRO, eDiary, Medidata Rave/EDC, Elluminate). Serve as a systems and governance leader (not hands-on DM activities like data cleaning/query resolution/database lock). Lead architecture, configuration, integration, and lifecycle management. Interface with CROs; manage internal Data Management systems team members.
Key Responsibilities
- Lead, mentor, and develop a team of clinical trial solutions personnel; set systems strategy/roadmap and performance metrics.
- Manage systems budgets, resourcing, vendor contracts, and staffing across concurrent systems/study portfolios.
- Own enterprise strategy, roadmap, and governance for clinical data systems; define access, role-based permissions, change/version control.
- Establish configuration standards, build templates, and reusable libraries.
- Lead vendor management (SLA definition, performance monitoring, renewal/negotiation).
- Lead selection/implementation of new systems and upgrades (RFPs, vendor due diligence).
- Oversee computer system validation (CSV/CSA) to meet 21 CFR Part 11, GxP, and data integrity requirements.
- Direct configuration, build, and testing for EDC/eCOA/eDiary/Elluminate; manage full system lifecycle (onboarding through decommissioning/archiving).
- Ensure disaster recovery, business continuity, and uptime/performance standards with IT.
- Lead integration architecture/oversight (e.g., EDC-to-eCOA, EDC-to-Elluminate, EDC-to-IRT/RTSM/safety); define specifications/APIs/mapping; troubleshoot systemic integration issues.
- Serve as systems SME for inspections/audits; maintain SOPs/validation documentation with QA; monitor regulatory guidance; own system-change risk assessments.
- Act as primary systems liaison to Clinical Data Management, Biostats, Clinical Ops/Development, Regulatory, Quality, and IT; provide input to protocol/study design/technology selection; educate/train stakeholders.
Required Qualifications
- Bachelor’s degree (life sciences, health info, CS, or related); advanced degree preferred.
- 15+ years in clinical data management and/or clinical data systems (pharma/biotech/CRO).
- Strong clinical data management foundation (DM planning, data cleaning/query mgmt/database lock) to inform systems decisions.
- 5+ years people management experience.
- Experience owning/administering eCOA/ePRO, eDiary, Medidata Rave/EDC, and Elluminate.
- Strong knowledge of CSV/CSA, 21 CFR Part 11, ICH-GCP, and global regulatory requirements.
- Proven record leading system implementations, upgrades, integrations, and vendor management; inspection/audit support experience.
Preferred Qualifications
- Experience across therapeutic areas and trial phases I–IV.
- Familiarity with IRT/RTSM, CTMS, safety databases, eTMF.
- Integration architecture/API/data pipeline/interface design experience.
- Certifications (e.g., CCDM, ITIL, PMP) and computer system validation/audit trail & data integrity frameworks.
Skills & Competencies
- Strategic, technology-forward thinking with strong operational execution; systems/governance mindset.
- People leadership; strong vendor management/negotiation/contract oversight.
- Translate business/process needs into scalable technical solutions; excellent written/verbal communication; comfortable in fast-paced matrixed org.
Work Environment
- Remote-based; travel 10–20%.
- Salary range: $260,000–$290,000 USD. Benefits may include medical/dental/vision/401k, unlimited paid time off, and parental leave (as stated).
Application Instructions
- Not provided in the text.
- Provide strategic and operational leadership for the clinical data technology ecosystem (eCOA/ePRO, eDiary, Medidata Rave/EDC, Elluminate). Serve as a systems and governance leader (not hands-on DM activities like data cleaning/query resolution/database lock). Lead architecture, configuration, integration, and lifecycle management. Interface with CROs; manage internal Data Management systems team members.
Key Responsibilities
- Lead, mentor, and develop a team of clinical trial solutions personnel; set systems strategy/roadmap and performance metrics.
- Manage systems budgets, resourcing, vendor contracts, and staffing across concurrent systems/study portfolios.
- Own enterprise strategy, roadmap, and governance for clinical data systems; define access, role-based permissions, change/version control.
- Establish configuration standards, build templates, and reusable libraries.
- Lead vendor management (SLA definition, performance monitoring, renewal/negotiation).
- Lead selection/implementation of new systems and upgrades (RFPs, vendor due diligence).
- Oversee computer system validation (CSV/CSA) to meet 21 CFR Part 11, GxP, and data integrity requirements.
- Direct configuration, build, and testing for EDC/eCOA/eDiary/Elluminate; manage full system lifecycle (onboarding through decommissioning/archiving).
- Ensure disaster recovery, business continuity, and uptime/performance standards with IT.
- Lead integration architecture/oversight (e.g., EDC-to-eCOA, EDC-to-Elluminate, EDC-to-IRT/RTSM/safety); define specifications/APIs/mapping; troubleshoot systemic integration issues.
- Serve as systems SME for inspections/audits; maintain SOPs/validation documentation with QA; monitor regulatory guidance; own system-change risk assessments.
- Act as primary systems liaison to Clinical Data Management, Biostats, Clinical Ops/Development, Regulatory, Quality, and IT; provide input to protocol/study design/technology selection; educate/train stakeholders.
Required Qualifications
- Bachelor’s degree (life sciences, health info, CS, or related); advanced degree preferred.
- 15+ years in clinical data management and/or clinical data systems (pharma/biotech/CRO).
- Strong clinical data management foundation (DM planning, data cleaning/query mgmt/database lock) to inform systems decisions.
- 5+ years people management experience.
- Experience owning/administering eCOA/ePRO, eDiary, Medidata Rave/EDC, and Elluminate.
- Strong knowledge of CSV/CSA, 21 CFR Part 11, ICH-GCP, and global regulatory requirements.
- Proven record leading system implementations, upgrades, integrations, and vendor management; inspection/audit support experience.
Preferred Qualifications
- Experience across therapeutic areas and trial phases I–IV.
- Familiarity with IRT/RTSM, CTMS, safety databases, eTMF.
- Integration architecture/API/data pipeline/interface design experience.
- Certifications (e.g., CCDM, ITIL, PMP) and computer system validation/audit trail & data integrity frameworks.
Skills & Competencies
- Strategic, technology-forward thinking with strong operational execution; systems/governance mindset.
- People leadership; strong vendor management/negotiation/contract oversight.
- Translate business/process needs into scalable technical solutions; excellent written/verbal communication; comfortable in fast-paced matrixed org.
Work Environment
- Remote-based; travel 10–20%.
- Salary range: $260,000–$290,000 USD. Benefits may include medical/dental/vision/401k, unlimited paid time off, and parental leave (as stated).
Application Instructions
- Not provided in the text.