Global Study Manager

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 aGlobal 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 theGlobal Study Lead (GSL), you'll contribute to the seamless end-to-end delivery of the clinical study. As the GSM, you will lead theOperational Working Group (for in-house studies) and actively participate as a key member of theCentral 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 webpageLife 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 Applications – 22nd of May 2026 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

As a focused biopharma company, we discover, develop and deliver medicines and vaccines to create value for patients and shareholders. We are on track to make a positive impact on the health of 2.5 billion people by the end of the decade. In R&D, we combine the science of the immune system with advanced technologies to develop new medicines and vaccines that can help transform people’s lives. We focus on four areas – respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – where we have the strongest expertise and significant patient need remains. By developing differentiated medicines and vaccines across these areas, we can deliver patient benefit at scale and generate value for people, health systems, shareholders and society.

Find out more:

Our approach to R&D.

#LI-GSK

Italian Salary Range / Fascia retributiva in Italia: EUR 53,475 to EUR 89,125 The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

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 at where you can also request a call.

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 Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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