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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical study management, including oversight of global clinical trials and compliance with regulatory standards such as ICH GCP and US CFR. Proficient in project management methodologies and tools, with a strong focus on budget management, vendor oversight, and effective communication.
Highest-signal resume keywords
Clinical Study ManagementICH GCP ComplianceProject Management ToolsVendor Selection and OversightRegulatory Inspection Preparedness
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementBudget ManagementData Review and AnalysisMonitoring Document ReviewProtocol Deviation AnalysisCTMS Data ManagementStudy Plan ReviewRisk Mitigation StrategiesOversight Monitoring VisitsDatabase Lock Support
Soft Skills
Leadership SkillsOrganizational SkillsCommunication SkillsInterpersonal SkillsDetail-Oriented
Tools & Technologies
Project Management ToolsCTMSRegulatory Filing SystemsDocument Tracking SystemsStoryboard Development Tools
Certifications & Qualifications
PMP CertificationPRINCE2 Certification
Industry Keywords
Pharmaceutical IndustryClinical Research OrganizationGlobal StudiesEarly Phase Clinical StudiesTherapeutic AreasRegulatory ComplianceLocal Country RequirementsInspection ReadinessStudy Team CoordinationSOPs
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- 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