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Global Study Manager

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GSK

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Location:
United Kingdom; Italy , London ▼

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This role within GCSD plays a pivotal part in driving the clinical operations of assigned studies, from Commit to Study Initiation (CSI) all the way through to study archiving. As a Global Study Manager (GSM), you'll take ownership of crafting robust, accelerated delivery plans that aim for top-tier performance—ensuring timelines, quality standards, and ambitious targets are consistently achieved. Collaborating closely with the Global Study Lead (GSL), you'll contribute to the seamless end-to-end delivery of the clinical study. As the GSM, you will lead the Operational Working Group (for in-house studies) and actively participate as a key member of the Central Study Team (CST). This is a dynamic and impactful role designed for individuals driven to make a meaningful difference in clinical operations.

Job Responsibility:

  • Be the Working Group (WG) Lead for Clinical Operations with accountability for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements
  • Be accountable for the following deliverables: Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Study Demographic and Diversity Plan, Vendors Oversight Plan, Results Dissemination Plan, Investigator/CRA Meeting Set Up & associated training, Expected Document List, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Patient Engagement Activities, CSDD KOM & template, Safety Management plan, Protocol Deviation Management Plan, eTMF & vendor set-up, Pharmacy Manual
  • Support assessment and selection of FSO vendors
  • Be accountable for holistic oversight of FSO vendors according to the FSO handbook
  • Be responsible for assessment and selection of other study vendors under GCSD responsibility in consultation with GSL
  • Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies
  • Balance risk/benefit to make decisions based on clear understanding of impact on the study and project
  • Proactively and effectively identify, oversee, and mitigate study risks
  • Ensure appropriate stakeholder communication, including study status, expectations, risks and issues
  • Be accountable to operate within the study budget
  • Effectively lead empowered matrix teams
  • Implement innovative approaches to study delivery through external facing advances in technology and sciences
  • Be responsible for operational input into protocol and informed consent form development, and other key study documents
  • Lead and conduct investigator meetings and other study related meetings
  • Lead quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies
  • Ensure data quality plans and end to end data cleaning is performed instream by the responsible line functions
  • Ensure Clinical Study Report is delivered on time and support GSK’s adherence to local regulatory guidance
  • Oversee the activities of the countries participating in the study
  • Provide support and coaching (where appropriate) to the SM
  • Be an ambassador in increasing utilization of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working

Requirements:

  • Bachelor’s degree: life sciences or related discipline
  • Good understanding of complex clinical development and regulatory processes
  • In-depth experience in clinical research: study management, monitoring, data management
  • Strong skills and experience in project management and tools
  • Strong performer / executor of operational tasks with strong skills and experience in study delivery
  • Experience of working across multiple types of study designs
  • In depth knowledge of GCPs and ICH guidelines
  • Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills
  • Demonstrates leadership skills, promoting motivation and empowerment of others
  • Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
  • Good project management skills (including scope, budget, timeline, and resource planning and management)
  • Able to lead and work within teams and networks across functional and geographical boundaries
  • Able to manage competing priorities, performance targets and project initiatives in a global environment
  • Operational expertise in risk management and contingency planning
  • Applies industry best practices to the design and execution of clinical studies
  • Demonstrates conceptual, analytical and critical thinking
  • Effective at problem solving and conflict resolution
  • Ability to manage change and uncertainty
  • Ability to delegate tasks
  • Demonstrates experience in multicultural settings
  • Demonstrates versatility and ability to adapt to working across multiple TAs
  • Ability to think independently, analyse and solve problems systematically and creatively, and to take a risk-based approach
What we offer:
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Pension plan membership
  • Shares and savings programme

Additional Information:

Job Posted:
March 27, 2026

Expiration:
April 07, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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