Role Summary
As Senior Director, Head of Integrated Clinical System Support, you will shape the future of Global Clinical Operations by leading a team of 40+ experts and overseeing a landscape of 100+ mission-critical clinical systems. You will drive operational excellence, maintain a compliant, effective, end-user friendly system landscape, and empower clinical study teams worldwide to deliver their studies efficiently and compliantly. This role is ideal for a senior leader who excels in operational leadership, compliance, and stakeholder support within complex clinical environments. Location: UK β London, Belgium β Wavre, Canada β Mississauga (Ontario), India β Karnataka β Vemgal Bangalore, UK β Hertfordshire β Stevenage, USA β Pennsylvania β Upper Providence, Poland β Warsaw.
Responsibilities
- Lead the strategic vision for a global team of 40+ experts, accountable for a landscape of 100+ clinical systems supporting seamless clinical study delivery.
- Design and implement a forward-thinking roadmap, including optimal outsourcing and partnership models, in collaboration with Technology and Innovation Leads, as well as Development Tech.
- Align support services with evolving technology and business needs, proactively advising on system landscape gaps, consolidation opportunities, and decommissioning strategies.
- Forecast changes in user demand and data volumes, ensuring scalable system and support capacity.
- Champion a culture of reliability and regulatory excellence across all clinical systems.
- Ensure full compliance with external and internal guidelines, regulations, and policies, maintaining robust documentation to demonstrate system reliability and fitness for purpose, architect and execute risk-proportionate Computer System Validation and oversee formal downstream impact analyses to prevent operational or compliance disruptions.
- Collaborate with Third Party Management to ensure external systems meet rigorous standards.
- Represent the team in audits and inspections, drive timely and successful CAPA completion.
- Deliver world-class support to internal and external users, ensuring users are well-trained, knowledgeable, and empowered.
- Provide onboarding and capability building for the use of new systems and system changes. Maintain a comprehensive repository of guides, FAQs, troubleshooting steps, and training materials.
- Operate a centralized, efficient helpdesk for investigator site users, ensuring rapid issue resolution and continuous improvement of support mechanisms.
- Deliver user account and access permission management as per appropriate user privileges and training status including periodic user access reviews.
- Define data archiving strategies and ensure execution to maintain system efficiency and compliance with data retention policies.
- Inspire, coach, and develop a global team, fostering an environment of empowerment, engagement, and alignment with GCO Working principles.
- Model the GSK values, champion professional growth, and cultivate a collaborative, high-performance culture.
Education
- Bachelorβs Degree in Life Sciences, Biomedical Engineering, Computer Sciences, Information Technology, or equivalent work experience.
Qualifications
- Required: Extensive senior leadership experience in clinical operations, systems management, and large matrixed environments.
- Required: Deep expertise in GxP, CSV, data security, IT infrastructure, and regulatory compliance.
- Required: Proven success in leading change, technology adoption, and process transformation.
- Required: Exceptional stakeholder management, communication, and negotiation skills.
- Required: Demonstrated ability to lead diverse teams and drive organizational excellence.
- Preferred: Masterβs Degree, PhD, MBA.