Global Study Manager

GSK; Warszawa; Hybrid; PLN 320,000 - 520,000; Full time

Benefits offered by this job

Hybrid work model

On-site 2–3 days a week

Job summary

GSK is seeking a Global Study Manager to drive end-to-end clinical operations from CSI to study archiving. You will lead operational planning, coordinate with the CST and GSL, and ensure delivery within time, budget and quality constraints.

Responsibilities include leading the WG for Clinical Operations, managing eTMF, budgets, vendors, and stakeholder communications, with on-site attendance 2–3 days weekly near a GSK hub.

Qualifications

• In-depth experience in clinical research: study management, monitoring, data management.
• Strong skills and experience in project management and tools.
• Excellent stakeholder management and communication skills.

Responsibilities

• Lead the operational delivery of clinical study to time, quality, and budget.
• Lead the Operational Working Group for Clinical Operations and participate in CST.
• Collaborate with GSL to ensure end-to-end study success and governance.
• Ensure adherence to ICH/GCP guidelines and GSK SOPs.
• Oversee budget tracking, eTMF processes, and vendor management.
• Lead investigator meetings and drive risk mitigation and issue resolution.

Skills

Project management

Clinical studies

Stakeholder communication

Education

Bachelor's degree in life sciences

Tools

Project management software

Data management systems

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

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 objective