Posted Date: Aug 1 2025
Senior Director, Head Integrated Clinical System Support
The Senior Director, Head Integrated System Support will manage a team of about 40 experts and will be accountable for providing proactive, effective, and efficient support services for a landscape of over 100 clinical systems used in the delivery of clinical studies, ensuring study teams can design and deliver their clinical studies seamlessly. The role has 4 key goals:
- Our landscape of clinical systems is reliable, appropriately validated, and compliant with relevant external and internal guidelines, regulations and policies.
- Our landscape of clinical systems is fit-for-purpose, effectively and efficiently enabling end-users to execute their tasks and processes.
- Our end-users, both internal (clinical study teams) as well as external (investigator site staff, third parties staff), are well trained and knowledgeable about the use of the systems, and receive the appropriate support when they experience challenges or difficulties.
- Administrative operations like management of user accesses and data archiving are smoothly delivered enabling un-interrupted and compliant system operations.
Key Responsibilities:
Strategy
- Design and implement a strong strategic vision, objectives and roadmap, including optimal outsourcing strategy and partnership models with Technology, Innovation and Business Leads as well as with Development Tech to align support services with technology changes.
Fit-for-Purpose System Landscape
- Ensure the clinical system landscape works flawlessly without data flow, operational or compliance challenges at system interfaces.
- Advice Technology, Innovation and Business Leads on gaps or overlaps in the system landscape and influence resolution including opportunities for consolidation and/or decommissioning.
- Ensure that the integrated system landscape and its individual systems is end-user centric and operates effectively and efficiently.
- Forecast changes in user demand / data volumes for systems and system support services. Ensure availability of systems as well as system support services capacity at scale.
Reliable and Compliant System Landscape
- Ensure all systems and the integrated system landscape comply with relevant external and internal guidelines, regulations and policies and that adequate documentation is maintained, archived and retrievable that demonstrate that systems are reliable, compliant and fit-for-purpose.
- Design and execution of risk-proportionate Computer System Validation strategies for new systems/system changes releasing only adequately compliant, reliable and effective systems for use, ensuring proactive identification, mitigation and documentation of business and compliance risks related to systems.
- Ensure execution of formal downstream impact analyses for system changes avoiding inadvertent disruption to operations, compliance, or business outcomes.
- Collaborate with Third Party Management teams to ensure reliability, compliance and fit-for-purpose of third-party systems used in clinical studies.
- Ensure appropriate representation from the integrated System Support team in audits and inspections and timely and successful completion of CAPAs from internal quality and performance issues as well as audit and inspection findings
End-user Support
- Ensure maintenance of a comprehensive repository of system-related guides, FAQs, trouble-shooting steps and training materials.
- Delivery of adequate onboarding support for new system users, training and other support programs for new systems or system changes including instructor-led trainings, e-learning modules, open door sessions, train-the-trainer approaches, and others.
- Ensure proactive and end-user centric communication on system updates, new features, known issues, planned outages, and resolutions in progress, and crisis management on critical system outages or incidents during disruptions and temporary workaround.
- End-user centric, efficient and effective centralized point of contact / helpdesk, particularly for investigator site users, to report issues, ask questions, or request assistance.
- Maintain and evolve procedures and mechanisms to monitor, diagnose and address problems reported by users.
Administrative Operations
- 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.
Leadership and Team Management
- Lead, manage, coach and develop a global team of associates enabling them to excel in their roles, live the GSK values, and grow professionally, fostering an environment where team members feel empowered, engaged, and are aligned with GCO Working principles.
Why You?
Basic Qualifications
- Bachelor’s Degree in Life Sciences, Biomedical Engineering, Computer Sciences, Information Technology, or related disciplines.
- Vast experience in clinical operations, clinical systems management, or related areas, with several years in senior leadership roles aligning clinical system operations with business goals and driving innovation.
- Vast leadership experience in people management and large matrixed environments.
- Experience and vast working knowledge of GxP, CSV, data security, and IT infrastructure.
- Experience in leading organizational change initiatives, including the adoption of new technologies, process improvements, and system upgrades.
- Experience in and strong grasp of emerging technologies, digital transformation, AI/ML applications, and their impact on clinical operations.
Preferred Qualifications
- Master’s Degree, PhD, MBA
- Proven track record in collaborating with various stakeholders, including clinical teams, IT professionals, regulatory bodies, and external vendors. This includes excellent communication and negotiation skills.
- Skilled at analysing complex challenges and implementing effective solutions.
- Ability to navigate a fast-paced, evolving environment and adapt to new technologies or regulatory changes.
- Strong ability to lead diverse teams, mentor staff, and foster a collaborative culture.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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