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Senior Director, Head of Integrated Clinical System Support
Senior Director, Head of Integrated Clinical System SupportGlaxoSmithKline • Collegeville, PA, US
Senior Director, Head of Integrated Clinical System Support

Senior Director, Head of Integrated Clinical System Support

GlaxoSmithKline • Collegeville, PA, US
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Overview

Senior Director, Head Integrated Clinical System Support

As Senior Director, Head of Integrated 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. This executive role is your opportunity to drive operational excellence, maintain a compliant, effective and 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.

Key Responsibilities

Strategy

  • 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.

Compliance

  • 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.
  • End-user Support

  • 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.
  • 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

  • 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.
  • Why You?

    Basic Qualifications

  • Bachelor's Degree in Life Sciences, Biomedical Engineering, Computer Sciences, Information Technology, or equivalent work experience.
  • Extensive senior leadership experience in clinical operations, systems management, and large matrixed environments.
  • Deep expertise in GxP, CSV, data security, IT infrastructure, and regulatory compliance.
  • Proven success in leading change, technology adoption, and process transformation.
  • Exceptional stakeholder management, communication, and negotiation skills.
  • Demonstrated ability to lead diverse teams and drive organizational excellence.
  • Preferred Qualifications

  • Master's Degree, PhD, MBA
  • LI-GSK

    Hybrid

    Why GSK?

    Why GSK?

    Uniting science, technology and talent to get ahead of disease together.

    GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas : respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

    People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

    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.

    We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

    Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391.

    The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

    Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive.

    Important notice to Employment businesses / Agencies

    GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https : / / openpaymentsdata.cms.gov /

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