Accountable for the execution of clinical trials in assigned countries in the region, ensuring delivery according to timelines, budget, and quality expectations
Monitor study progress against milestones and proactively manage risks, issues, and contingencies
Ensure compliance with ICH-GCP, SOPs, and applicable regulatory requirements
Provide functional oversight and guidance to assigned CRAs, ensuring high-quality monitoring and performance
Supervise CRA training at study level (protocol, monitoring plan, study tools, etc.)
Accompany CRAs on key visits (e.g., SIVs, audits) as needed to support study conduct and site engagement
Review and approve monitoring visit reports and follow-up communications
Ensure protocol adherence and oversee protocol deviations, root cause analyses, and CAPA implementation
Support inspection readiness and oversee audit findings resolution
Perform or support Study Evaluation Visits (SEVs) when required
Act as a key interface between sponsor and operational teams, ensuring alignment and transparent communication
Collaborate cross-functionally to support milestone achievement and resolution of study issues
Develop and maintain study plans and timelines, ensuring on-time delivery
Organize regular study follow-up meetings with CRAs and stakeholders
Provide structured feedback on team performance and contribute to continuous improvement.

Bachelor’s degree in Life Sciences or related field
Minimum 3+ years as Project Manager and 5+ years of clinical research experience
Very good knowledge of clinical trial conduct, ICH-GCP, and regulatory requirements
Experience in set-up and conduct of Early Phase – Phase I Clinical Trials
Therapeutic area knowledge in Oncology, Hematology, or Heart Failure would be an advantage
Proven experience in site management, CRA oversight, and cross-functional coordination
Strong communication and stakeholder management skills
Ability to manage multiple priorities in a matrix environment
Fluent in English and knowledge of local language (Hungarian/ Romanian)
Strong operational leadership and coordination capabilities
Excellent problem-solving and risk management skills
Strong attention to quality, compliance, and detail
High level of collaboration across teams, functions, and geographies
Ability to travel nationally and internationally as required (approx. every 2–3 months).

Clinical Operations Project Manager

Key skills