Global Study Manager

GSK

. Own operational delivery of assigned clinical studies from Commit to Study Initiation through study archiving .

Posted 10/30/2026full-timeWarsaw • PolandMid-LevelSenior💰 PLN 269,250 - PLN 448,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical study management, including operational delivery, project management, and compliance with ICH/GCP guidelines. Proven ability to lead cross-functional teams, manage vendor relationships, and ensure data quality throughout the study lifecycle.

Highest-signal resume keywords

Clinical Study ManagementProject ManagementGCP ComplianceStakeholder ManagementRisk Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical ResearchStudy DeliveryData ManagementBudget TrackingETMF FilingProtocol DevelopmentVendor OversightStudy DesignPerformance Target ManagementRegulatory Processes

Soft Skills

LeadershipInterpersonal SkillsCommunication SkillsProblem SolvingAdaptability

Tools & Technologies

Project Management ToolsAI/ML ToolsETMF SystemsData Quality Plans

Industry Keywords

ICH GuidelinesGCPsClinical OperationsDrug DevelopmentMulticultural Settings

About the role

Key responsibilities & impact

Own operational delivery of assigned clinical studies from Commit to Study Initiation through study archiving
Craft accelerated delivery plans to achieve timelines, quality standards and performance targets
Lead the Clinical Operations Operational Working Group and participate in the Central Study Team
Deliver study initiation meetings, clinical study activity plans and study delivery plans
Develop TMF quality strategy, DCT setup, demographic and diversity plans, vendor oversight plans and results dissemination plans
Set up investigator/CRA meetings and associated training
Manage expected document lists, recruitment tracking, budget tracking, eTMF filing and vendor setup/management
Lead patient engagement activities, safety management, protocol deviation management, pharmacy manual development and CSDD kickoff/template activities
Support assessment and selection of FSO vendors and other study vendors
Provide holistic oversight of FSO vendors
Ensure compliance with ICH/GCP guidelines, applicable laws, regulations and GSK SOPs
Identify, oversee and mitigate study risks
Communicate study status, expectations, risks and issues to stakeholders
Operate within the study budget and lead empowered matrix teams
Implement innovative technology- and science-enabled approaches to study delivery
Provide operational input into protocols, informed consent forms and other study documents
Lead investigator and study-related meetings
Lead quality efforts for protocol compliance and inspection readiness
Ensure data quality plans and end-to-end data cleaning are completed
Ensure timely delivery of the Clinical Study Report
Oversee activities of countries participating in the study
Support and coach Study Manager Ambassadors in AI/ML tool adoption, automation and efficiency improvements

Requirements

What you’ll need

Bachelor’s degree: life sciences or related discipline
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 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
Leadership, motivation and empowerment skills
Strong understanding of clinical study, drug development, sample management, associated processes and quality requirements
Project management skills including scope, budget, timeline and resource planning and management
Ability to lead and work within teams and networks across functional and geographical boundaries
Ability to manage competing priorities, performance targets and project initiatives in a global environment
Operational expertise in risk management and contingency planning
Industry best practices in clinical study design and execution
Conceptual, analytical and critical thinking
Problem solving and conflict resolution
Ability to manage change and uncertainty
Ability to delegate tasks
Experience in multicultural settings, including working with remote teams
Versatility and ability to adapt across multiple therapeutic areas
Independent, systematic and creative problem solving with a risk-based approach

Benefits

Comp & perks

Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours
Annual bonus
Eligibility to participate in share based long term incentive program
Medical Plan
Life Insurance
Employee Retirement Program
Sport and recreation cards
Recreation allowance
Additional paid days off
Private pension plan
Fully paid parental leave and leave to care for a family member
Supportive & friendly working environment
Inclusive employer; recruitment adjustments available