Senior Director, Data Management Systems

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $260 000 - $290 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Immunovant

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2018

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Immunovant est une entreprise dédiée à l'avancement des traitements pour les maladies auto-immunes grâce à une approche centrée sur le patient. Avec pour vision de permettre une vie normale aux personnes atteintes de maladies auto-immunes, Immunovant utilise son expertise scientifique pour développer et tester de nouvelles thérapies. L'entreprise met l'accent sur les besoins complexes et variés à travers les différents stades et degrés de gravité des maladies. Immunovant s'engage à faire progresser ses domaines thérapeutiques et ses essais cliniques, tout en dialoguant avec les patients, les aidants et les investisseurs au sujet de leurs études en cours et de leurs initiatives d'entreprise.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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%)