Senior Director, Head of Integrated Clinical System Support

Role Summary

Senior Director, Head of Integrated Clinical System Support. Lead a global team of 40+ experts overseeing 100+ mission-critical clinical systems to drive operational excellence, compliance, and end-user friendly system landscape for global clinical operations.

Responsibilities

• Lead the strategic vision for a global team accountable for a landscape of clinical systems supporting seamless clinical study delivery.
• Design and implement a forward-thinking roadmap with outsourcing and partnership models in collaboration with Technology and Innovation Leads and Development Tech.
• Align support services with evolving technology and business needs; advise on system landscape gaps, consolidation, and decommissioning strategies.
• Forecast changes in user demand and data volumes to ensure scalable system and support capacity.
• Champion reliability and regulatory excellence across all clinical systems; ensure compliance with guidelines, regulations, and policies; maintain documentation for system reliability and fitness for purpose; architect and execute risk-proportionate Computer System Validation and oversight of downstream analyses to prevent disruptions.
• Collaborate with Third Party Management to ensure external systems meet standards; represent the team in audits and inspections; drive CAPA completion.
• Deliver world-class end-user support; ensure users are trained and empowered; provide onboarding and capability building for new systems; maintain guides, FAQs, troubleshooting steps, and training materials.
• Operate a centralized helpdesk for investigator site users with rapid issue resolution and continuous improvement of support mechanisms.
• Manage user accounts and access permissions; conduct periodic access reviews; define and execute data archiving strategies and retention compliance.
• Inspire, coach, and develop a global team; align with GCO Working principles; model company values and cultivate a collaborative, high-performance culture.

Qualifications

• Required: Bachelor‚Äôs Degree in Life Sciences, Biomedical Engineering, Computer Sciences, Information Technology, or equivalent; extensive senior leadership experience in clinical operations, systems management in large matrixed environments; deep expertise in GxP, CSV, data security, IT infrastructure, and regulatory compliance; proven change leadership and technology adoption; exceptional stakeholder management and communication skills; demonstrated ability to lead diverse teams.
• Preferred: Master‚Äôs Degree, PhD, MBA.

Skills

• Operational leadership in complex clinical environments
• Regulatory compliance and quality systems (CSV, GxP)
• Strategic roadmapping and project governance
• Stakeholder management and negotiation
• Change management and technology adoption
• End-user training and knowledge management

Education

• Bachelor‚Äôs Degree (required); Master‚Äôs Degree, PhD, or MBA (preferred).

Additional Requirements

• Hybrid work model.