Clinical Study Manager

• Support execution of selected clinical studies in compliance with ICH GCP, local regulations, and SOPs
• Plan and operationally execute specific tasks within assigned clinical trials
• Coordinate with functional leads to deliver milestones and meet project objectives
• Oversee CRO/vendor selection, budget and contract negotiation, and Strategic Partner performance
• Escalate issues to governance committees when warranted
• Review and approve monitoring documents and plans, and review monitoring outputs, decisions, and actions
• Conduct Oversight Monitoring Visits when applicable
• Review and endorse relevant study plans
• Manage and attend study team meetings and review agendas and minutes
• Review protocol deviation outcomes and actions to identify trends across sites and studies
• Monitor study-level issues, risks, and decisions and implement mitigation strategies
• Own and review trial operational data, including CTMS data
• Provide oversight of internal trial reports
• Ensure studies remain inspection ready and support regulatory inspections
• Prepare for agency inspections, including document readiness, tracking, and storyboard development
• Support data review for database lock and CSR writing and review, including appendices
• Collect, review, and file study documents for the trial master file and regulatory filing

• 5+ years’ experience in pharmaceutical industry and/or clinical research organization
• 3+ years clinical study management oversight, including significant study management support experience as Project Manager/CTM on a global level
• Experience in early phase clinical studies or Phase 2 and 3 studies
• Experience in global/international studies or programs
• Experience in more than one therapeutic area is advantageous
• Proven track record of successfully managing projects within scope, time, and budget constraints
• Experience in vendor selection and oversight
• Strong leadership and organizational skills
• Excellent communication and interpersonal skills
• Knowledge of global regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP
• Awareness of local country requirements may be required
• Proficiency in project management tools and methodologies
• PMP or PRINCE2 certification is advantageous
• Detail-oriented, proactive, and adaptable
• Fluent business English, oral and written
• Legal right to work in Poland

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways