Global Study Manager

Job Purpose:

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.

• GSM will 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, supporting decision-making at pace and leading study team to achieve overall study deliverables
• As Operational WG Lead, GSM is accountable for the following deliverables (to be adjusted accordingly for the STOM FSO model):
  • 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
• Supports assessment and selection of FSO vendors
• Accountable for holistic oversight of FSO vendors according to the FSO handbook
• Responsible for assessment and selection of other study vendors under GCSD responsibility in consultation with GSL
• Ensures compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies.understand study contribution to program/submission
• Balances risk/benefit to make decisions based on clear understanding of impact on the study and project
• Proactively and effectively identifies, oversees, and mitigates study risks
• Ensures appropriate stakeholder communication, including study status, expectations, risks and issues
• Accountable to operate within the study budget
• Effectively leads empowered matrix teams
• Implements innovative approaches to study delivery through external facing advances in technology and sciences and encourages others within matrix and line teams to seek innovative perspectives and develop solutions.
• Responsible for operational input into protocol and informed consent form development, and other key study documents.
• Leads and conducts investigator meetings and other study related meetings
• Leads quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies
• Ensures data quality plans and end to end data cleaning is performed instream by the responsible line functions
• Ensures Clinical Study Report is delivered on time and supports GSK’s adherence to local regulatory guidance
• Oversees the activities of the countries participating in the study
• Provides support and coaching (where appropriate) to the SM
• Ambassadors in increasing utilization of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working
• This role is hybrid and requires candidates to live in proximity to a GSK hub.

• Bachelor’s degree: life sciences or related discipline
• The role will require a 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…