Job ID: 433996
Function: Medical & Clinical Operations
Employment Type: Full-Time
Work Model: Hybrid (Must reside near a GSK hub)
Experience Required: 7–12+ Years in Clinical Research & Study Management
Locations:
Mississauga, Canada | Wavre, Belgium | Bengaluru, India | Siena, Italy | Stevenage, United Kingdom | Collegeville, Pennsylvania, USA | Warsaw, Poland
About GSK
GSK is a leading global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. With a strong focus on vaccines and specialty medicines across respiratory, immunology, oncology, HIV, and infectious diseases, GSK aims to positively impact billions of lives worldwide.
Operating across major global hubs, GSK fosters a culture rooted in patient focus, accountability, innovation, and ethical leadership.
Role Overview
The Global Study Manager (GSM) plays a critical leadership role within Global Clinical Study Delivery (GCSD), overseeing the end-to-end operational management of clinical trials from Commit to Study Initiation (CSI) through study close-out and archiving.
This position requires a highly experienced clinical operations professional with deep expertise in global trial management, vendor oversight, ICH/GCP compliance, budget management, and cross-functional leadership. The GSM partners closely with the Global Study Lead (GSL) and leads Operational Working Groups to ensure clinical trials are delivered on time, within budget, and in accordance with quality and regulatory standards.
Key Responsibilities
Global Clinical Trial Delivery
Lead operational delivery of global clinical studies to defined timelines, quality standards, scientific objectives, and budget targets.
Develop and execute key study documents and plans, including:
Study Delivery Plan
Clinical Study Activity Plan
Vendor Oversight Plan
Risk Management & Safety Plans
Recruitment & Diversity Strategy
TMF Quality Strategy
Results Dissemination Plan
Ensure timely and compliant delivery of the Clinical Study Report (CSR).
Oversee country-level study execution and coordinate across geographies.
Vendor & Budget Oversight
Assess and select Functional Service Organization (FSO) vendors and other study vendors.
Provide holistic oversight in accordance with governance frameworks.
Track study budgets, vendor performance, and financial compliance.
Regulatory & Quality Compliance
Ensure adherence to ICH/GCP guidelines, global regulatory requirements, and internal SOPs.
Maintain inspection readiness and oversee protocol deviation management.
Contribute to protocol development, informed consent documentation, and pharmacy manuals.
Ensure robust data quality oversight and end-to-end data cleaning processes.
Risk Management & Innovation
Identify, assess, and mitigate operational risks using structured contingency planning.
Apply industry best practices to improve study efficiency and cost-effectiveness.
Promote adoption of AI/ML tools and automation to enhance clinical trial operations.
Leadership & Stakeholder Engagement
Lead cross-functional matrix teams across global regions.
Facilitate investigator meetings and study-related governance sessions.
Communicate study status, risks, and mitigation strategies to stakeholders.
Coach and support Study Managers (SMs) where appropriate.
Required Qualifications
Bachelor’s degree in Life Sciences or related discipline (advanced degree preferred).
7–12+ years of experience in clinical research, including study management, monitoring, or data management.
Proven experience managing global, multi-country clinical trials.
Strong knowledge of ICH/GCP guidelines and global regulatory frameworks.
Demonstrated expertise in project management, including scope, timelines, budgets, and resource allocation.
Experience working with multiple study designs and therapeutic areas.
Strong stakeholder management, communication, and leadership capabilities.
Ability to operate in multicultural, cross-regional environments.
Core Competencies
Advanced risk management and contingency planning skills.
Analytical and critical thinking capability.
Effective conflict resolution and problem-solving skills.
Strong adaptability in complex, fast-paced global environments.
Experience leveraging digital tools and AI-driven efficiencies in clinical operations.
Compensation (Location-Specific Transparency)
Poland: PLN 269,250 – 448,750 gross annually (based on experience and market benchmarks).
Canada (Ontario): CAD 117,000 – 167,000 annually (based on qualifications and internal equity).
Additional benefits may include annual performance bonuses, private healthcare, retirement plans, paid leave programs, and other country-specific statutory benefits.
Why Join GSK
Work at the forefront of global clinical development.
Lead complex, high-impact clinical programs across multiple therapeutic areas.
Be part of a purpose-driven organization advancing innovative medicines and vaccines.
Thrive in a collaborative culture focused on scientific excellence and patient impact.
Inclusion & Recruitment Transparency
GSK is committed to diversity, equity, and inclusion. Adjustments during the recruitment process are available upon request.
GSK does not charge any fees during recruitment and does not accept unauthorized agency submissions. Applicants are encouraged to apply only through official GSK channels.
Apply Through ThePharmaDaily.com
Experienced clinical operations leaders seeking global exposure and strategic trial oversight opportunities are encouraged to apply. Join a leading biopharma organization dedicated to accelerating clinical innovation and delivering meaningful outcomes for patients worldwide.
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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