Global Study Manager (12 months)

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. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 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 follows GSK’s Performance with Choice flexible‑working approach—balancing individual flexibility with team collaboration—and requires on‑site attendance 2–3 days per week to support core team activities and business needs. Candidates are required to live in proximity to a GSK hub. Why You? Basic Qualifications We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Education Requirements: Bachelor’s degree: life sciences or related discipline The role will require a good understanding of complex clinical development and regulatory processes. Job Related Experience: 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, analyze and solve problems systematically and creatively, and to take a risk-based approach. What we offer: Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours. Established job in an international, well-known pharmaceutical company. Opportunity to work in professional team plays crucial role in maintaining GSK portfolio on the markets. Opportunity to work within GSK standards and documentation applied globally. Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus). Supportive & friendly working environment. We’re looking for someone who thrives in a collaborative environment, is passionate about delivering results, and is eager to make a difference. If this sounds like you, we’d love to hear from you! #LI-GSK #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.
 As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs. 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/