Global Clinical Project Manager

The Global / International Clinical Project Manager is responsible for the operational planning, coordination, execution, and oversight of clinical trials across multiple countries and regions. Acting as a key point of contact for cross-functional teams and external partners, this role ensures that clinical studies are delivered in accordance with agreed timelines, budgets, quality standards, and regulatory requirements.

The position oversees clinical trial activities throughout the study lifecycle, from initial planning and study start-up through execution and close-out, ensuring effective collaboration, proactive risk management, and operational excellence.

Scope and responsibilities

• Manage the operational planning, execution, and oversight of international and/or global clinical studies from start-up through close-out.
• Develop, implement, and maintain study timelines, project plans, and operational strategies.
• Ensure clinical trials are conducted in compliance with applicable regulations, ICH-GCP guidelines, study protocols, and relevant procedures.
• Coordinate cross-functional study teams, working closely with Clinical Operations, Data Management, Biostatistics, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other relevant functions.
• Monitor study progress against key milestones, deliverables, timelines, budgets, and quality objectives.
• Identify, assess, and proactively manage study risks, issues, and dependencies, implementing mitigation strategies and escalating when appropriate.
• Coordinate and oversee the activities and performance of CROs, vendors, laboratories, and other external service providers.
• Monitor study performance metrics and operational data to support decision-making and optimize study execution.
• Coordinate study start-up activities, including feasibility assessments, country and site selection, enrollment planning, and vendor engagement.
• Ensure effective communication, collaboration, and alignment between internal and external stakeholders across different countries and regions.
• Lead or participate in study team meetings and provide regular project status updates to relevant stakeholders and management.
• Manage and monitor study budgets, forecasts, and resource requirements in collaboration with relevant stakeholders.
• Contribute to the preparation, review, and maintenance of study-related documentation, including operational plans, study manuals, vendor scopes of work, and project reports.
• Support ongoing inspection readiness and participate in audits and regulatory inspections as required.
• Facilitate cross-functional decision-making and timely resolution of operational challenges.
• Document lessons learned and contribute to the implementation of best practices across clinical studies.
• Support continuous improvement initiatives to enhance clinical trial quality, efficiency, and operational performance.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related discipline.
• Several years of relevant experience in Clinical Operations, Clinical Trial Management, or Clinical Project Management within the pharmaceutical, biotechnology, medical device, or CRO industry.
• Proven experience in managing or coordinating international and/or global clinical trials across multiple countries and sites.
• Good understanding of clinical trial processes, ICH-GCP guidelines, and applicable regulatory requirements.
• Experience in CRO and external vendor oversight and management.
• Strong project management, planning, organizational, and stakeholder management skills.
• Ability to coordinate and lead cross-functional teams in an international environment.
• Strong analytical, problem-solving, risk management, and decision-making skills.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with diverse stakeholders.
• Ability to manage multiple priorities and work effectively in a dynamic, international environment.
• Excellent written and verbal communication skills in English.