Hybrid Study Manager

at GSK

• Job title: Study Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: PLN 186,750 - PLN 311,250 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Warsaw, Poland

About the role

• Study Manager at GSK, leading clinical and evidence generation studies from planning through close-out. Collaborating across teams to ensure studies are timely and compliant with standards.

Responsibilities

• Monitor study conduct and progress; identify, resolve and escalate risks/issues.
• Draft and review key clinical documents (Protocol, ICF) and study plans.
• Coordinate meetings and collaboration with internal teams and external partners (CROs, vendors).
• Support GSM in CRO oversight and delivery of delegated activities.
• Serve as primary vendor contact for study-specific deliverables.
• Provide country-level oversight: recruitment, data completeness, deviations, regulatory compliance.
• Manage study communications: meetings, newsletters, action logs and team rosters.
• Oversee clinical supply and investigational product delivery; identify risks and propose mitigations.
• Ensure eTMF inspection readiness; maintain completeness and quality of study documentation.
• Oversee budget tracking, change orders and expenses; ensure alignment with agreements and escalate issues.
• Actively contribute to Study Leadership and Central Study Teams; foster team dynamics and change adoption.

Requirements

• At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
• Knowledge of clinical trials, drug development process.
• Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
• Well familiar with key systems used in clinical trial delivery.
• Experience in using Trial Master File industry accepted standard.
• Project management skills (preferably with analytical/financial skills) and good leadership skills.
• Excellent verbal and written communication in English.
• Strong knowledge of, and skills in applying, applicable clinical trial regulatory requirements, i.e. GCP and ICH guidelines.
• Ability to manage multiple competing priorities with leadership guidance across various clinical studies with good planning, time management and prioritization skills.
• Logical/analytical thinking and an inclination to spot patterns and outliers.
• Quality mindset, critical sense, attention to details, effective training and mentoring skills.
• Knowledge of project finance and accounting principles to understand budget, invoices, cross-charges and expense reports.
• Excellent comprehension of Microsoft Office tools and CTM systems.
• Good stakeholder management and communication skills (oral and written), strong interpersonal skills.
• Results driven and efficient.
• Ability to adjust to work in cross-functional squads in the agile model.

Benefits

• Medical Plan
• Life Insurance
• Employee Retirement Program
• Sport and recreation cards
• Recreation allowance
• Annual bonus