Clinical Operations Project Manager

Clinical Operations Project Managers are an integral part of clinical trial delivery working closely with clinical teams and sponsors to improve patients lives by bringing new drugs to market faster.

Within a sponsor-dedicated Functional Service Provider (FSP) model the Clinical Operations Project Manager (COPM) is an essential member of the core project team responsible for the operational delivery of clinical studies at regional level.

The COPM ensures studies are conducted in accordance with contractual requirements timelines quality standards and applicable regulations. This role combines hands-on clinical operations oversight with strong project coordination and stakeholder management with a particular focus on site-facing activities CRA functional leadership and execution excellence.

Main Responsibilities

Study Oversight & Delivery
Accountable for the execution of clinical trials in assigned countries in the region (Southeast Europe) 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

CRA Functional Management & Site Engagement
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

Quality & Compliance
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

Project Coordination & Stakeholder Management
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

Planning & Performance Management
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

Required Skills and Qualifications
Bachelors 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 and Phase II 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 23 months)

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