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, 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
• 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)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.