Global Study Manager

GlaxoSmithKline; Warszawa; Hybrid; PLN 269,000 - 449,000; Full time

Benefits offered by this job

Flexible working

Hybrid office model (2–3 days onsite)

Competitive compensation

Job summary

GlaxoSmithKline Poland seeks an experienced Global Study Manager to drive clinical operations from CSI to archiving. You will craft accelerated delivery plans, manage timelines, quality and budget, and lead the Operational Working Group while collaborating with the Global Study Lead to deliver end-to-end study success.

In this hybrid role, you will attend core team activities on-site 2–3 days per week and mentor team members. A strong background in clinical development and GCP is required.

Qualifications

• Bachelor’s degree in life sciences or related discipline.
• Strong understanding of clinical development and regulatory processes.
• Experience in clinical research: study management, monitoring, data management.

Responsibilities

• Lead operational delivery of clinical studies, ensuring timelines, quality and budget are met.
• Coordinate with GSL and CST to drive end-to-end study execution.
• Lead Operational WG for in-house studies and participate in study team governance.
• Ensure ICH/GCP compliance and risk management across studies.

Skills

Project management

Stakeholder management

ICH/GCP knowledge

Clinical study delivery

Risk management

Education

Bachelor’s degree in life sciences or related discipline

Job description

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

As Operational WG Lead, GSM is accountable for the following deliverables (to be adjusted accordingly for the STOM FSO model):

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.

Basic Qualifications

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.

Skills

Agile Thinking, Business Acumen, Clinical Development, Clinical Document Management, Clinical Trial Designs, Clinical Trials Monitoring, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, Pharmaceutical Industry, Project Management, Time Management Polish Salary Range / Polski przedział wynagrodzenia: PLN 269,250 to PLN 448,750The 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.Roczny przedział wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osób na tym stanowisku został wskazany powyżej dla każdej właściwej lokalizacji. Przedziały te uwzględniają szereg czynników, w tym umiejętności kandydata, doświadczenie, poziom wykształcenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zależności od stanowiska i obowiązujących polityk wewnętrznych, rola ta może również uprawniać do otrzymania premii (jeśli ma zastosowanie i jest przyznawana na podstawie określonych, obiektywnych kryteriów) oraz/lub nagród za wyjątkowe wyniki (przyznawanych według uznania pracodawcy). Wszystkie świadczenia ustawowe będą zapewnione zgodnie z przepisami prawa polskiego. Mogą być także oferowane dodatkowe benefity, takie jak prywatna opieka medyczna, dodatkowe płatne dni wolne, ubezpieczenie na życie, prywatny plan emerytalny oraz w pełni płatny urlop rodzicielski i urlop na opiekę nad członkiem rodziny. Bardziej szczegółowe informacje na temat całkowitego pakietu wynagrodzenia i świadczeń przypisanego do tego stanowiska zostaną przekazane podczas procesu rekrutacyjnego. Przedziały wynagrodzenia dla innych krajów mogą być również widoczne, ponieważ na niektórych rynkach obowiązują przepisy dotyczące jawności wynagrodzeń, które wymagają zamieszczania takich informacji w ogłoszeniach o pracę, a wskazane lokalizacje mogą stanowić potencjalne miejsce wykonywania tej roli. Jeśli przedział wynagrodzenia nie jest podany w ogłoszeniu dla konkretnej lokalizacji lub kraju, odpowiednie informacje o wynagrodzeniu zostaną omówione w trakcie procesu rekrutacyjnego. Prosimy pamiętać, że poziom wynagrodzenia różni się w zależności od kraju i jest ustalany na podstawie umiejętności, doświadczenia, poziomu wykształcenia oraz rynkowego poziomu wynagrodzenia dla danego stanowiska. Oferty są zazwyczaj przedstawiane w granicach wskazanego przedziału, z uwzględnieniem umiejętności, doświadczenia i kwalifikacji kandydata, przy czym górna granica jest zwykle zarezerwowana dla kandydatów o bardzo dużym doświadczeniu lub w innych wyjątkowych okolicznościach zgodnych z tymi kryteriami.

As an Inclusive employer, we encourage you to reach out if you need any adjustments 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.

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.