Senior Director, Head of Integrated Clinical System SupportJoin to apply for the Senior Director, Head of Integrated Clinical System Support role at myGwork - LGBTQ+ Business CommunitySenior Director, Head of Integrated Clinical System Support1 day ago Be among the first 25 applicantsJoin to apply for the Senior Director, Head of Integrated Clinical System Support role at myGwork - LGBTQ+ Business CommunityGet AI-powered advice on this job and more exclusive features.This job is with GSK, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Senior Director, Head Integrated Clinical System SupportAboutThe 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 ResponsibilitiesStrategyDesign 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 LandscapeEnsure 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 LandscapeEnsure 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 findingsEnd-user SupportEnsure 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 OperationsDeliver 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 ManagementLead, 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 QualificationsBachelor'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 QualificationsMaster's Degree, PhD, MBAProven 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.#Hybrid*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.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/ AgenciesGSK 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/Seniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionOtherIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at myGwork - LGBTQ+ Business Community by 2xSign in to set job alerts for “Head of Support” roles.London, England, United Kingdom 3 days agoDeputy Director - Head of Police Performance Improvement UnitLondon, England, United Kingdom 1 week agoHounslow, England, United Kingdom 1 week agoLondon, England, United Kingdom 1 month agoLondon, England, United Kingdom 3 days agoSenior Director, Head of Integrated Clinical System SupportLondon, England, United Kingdom 2 days agoWindsor, England, United Kingdom 3 days agoHR Business Partner-Maternity Cover, HR Business Partner-Maternity CoverUxbridge, England, United Kingdom 2 weeks agoIT Manager | Global Creative Agency | LondonDirector of Software Asset and Configuration ManagementLondon, England, United Kingdom 1 week agoLondon, England, United Kingdom 1 week agoLondon, England, United Kingdom 2 weeks agoLondon, England, United Kingdom 2 months agoLondon, England, United Kingdom 2 weeks agoLondon, England, United Kingdom 2 days agoAshford, England, United Kingdom 1 week agoLondon, England, United Kingdom 1 week agoSenior Manager, Monitoring, Evaluation and LearningSenior Manager, Monitoring, Evaluation and LearningLondon, England, United Kingdom 1 week agoWatford, England, United Kingdom 1 month agoLondon, England, United Kingdom 1 month agoLondon, England, United Kingdom 3 weeks agoResidential AV Commissioning Engineer / Technical LeadLondon, England, United Kingdom 8 months agoLondon, England, United Kingdom 3 weeks agoLondon, England, United Kingdom 2 weeks agoLondon, England, United Kingdom 5 days agoLondon, England, United Kingdom 3 days agoLondon, England, United Kingdom 1 month agoBusiness Partner, Finance Systems Insight & SimplificationLondon, England, United Kingdom 2 weeks agoLondon, England, United Kingdom 1 week agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr