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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.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
In this role you 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
*Be 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
*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. Understand study contribution to program/submission
*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 and encourage others within matrix and line teams to seek innovative perspectives and develop solutions.
*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
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
*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 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 in order to accomplish individual, team and organizational objectives
*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, and use of associated tools and support where available)
*Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others
*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 to improve time and cost efficiency
*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 (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams)
*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.
Closing Date for...