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.

Key responsibilities include, but are not limited to :

• 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.

Education Requirements :

Job Related Experience :

#LI-Hybrid

The annual base salary in Poland for new hires in this position ranges from PLN 269,250 to PLN 448,750 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and / or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.

More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. 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 market rate for the role.In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD117,000 to CAD167,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.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.

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.

Inclusion at GSK :

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at to discuss your needs.

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