Senior Project Coordinator in Soest, Utrecht at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Project Coordinator based in Netherlands.

As a Senior Project Coordinator, you will play a key role in supporting site activation and site-level deliverables throughout the clinical trial lifecycle. You will collaborate closely with Project Managers, Clinical Trial Managers, Site Selection teams, CRAs, clinical sites, and other stakeholders. The role combines project coordination, regulatory documentation, communication, and operational oversight in a global, multi-regional environment. You will take ownership of timelines, quality, and priorities to help ensure sites are activated efficiently and trials remain on track. As a senior team member, you will work autonomously while also supporting and mentoring junior colleagues when needed. This is an opportunity to make a tangible impact in a fast-growing clinical research environment while contributing to the successful delivery of clinical trials.

• Coordinate site activation activities from site selection through activation, ensuring timelines, targets, and deliverables meet internal and external expectations.
• Prepare investigator sites for clinical trials by reviewing, collecting, approving, filing, and tracking essential clinical and regulatory documentation.
• Establish site activation timelines with selected sites and coordinate activities across stakeholders to achieve planned activation milestones.
• Serve as a key point of contact for clinical sites during site start-up, maintaining clear communication and ensuring priorities remain aligned with study timelines.
• Collaborate with Project Managers, Clinical Trial Managers, CRAs, Site Selection teams, and other functional departments to coordinate activities and resolve issues.
• Identify risks to site activation schedules and escalate relevant issues to the Project Manager in a timely manner.
• Ensure the electronic Trial Master File (eTMF) contains complete, accurate, and appropriate regulatory documentation for site activation and ongoing study management.
• Support local ethics submissions and assist sites with regulatory and administrative requirements.
• Collect and distribute documents and study correspondence between sites and internal teams, while maintaining study files and required tracking logs.
• Coordinate internal project-specific training, including document assignments, reconciliation, and training documentation.
• Maintain project timelines, enrollment tracking tools, study material inventories, and other project tracking systems.
• Prepare meeting minutes, status reports, project updates, and other administrative documentation required by the project team.
• Support the preparation and shipment of study supplies and Investigator Study Files to clinical sites, where applicable.
• Assist with Investigators’ Meetings and provide in-house support to CRAs when they are traveling.
• Review and reconcile investigator site and vendor payments.
• Provide support for Health Authority inspections, pre-inspection activities, audits, and the preparation of corrective and preventive actions (CAPA) when required.
• Contribute to process improvement initiatives and the development of training materials within the Site Activation and Project Coordination function.
• Take on selected project management responsibilities when assigned and support broader project objectives as required.
• Mentor junior Project Coordinators and contribute to onboarding and knowledge-sharing activities.

• Bachelor’s degree in clinical research or a related field, or equivalent relevant professional experience.
• A specialized graduate diploma in drug development is considered an asset.
• At least 2 years of experience as a Project Coordinator or in an equivalent clinical research position within the biotechnology, pharmaceutical, and/or CRO industry.
• Demonstrated Site Start-Up experience supporting clinical trials and/or teams in a global or multi-regional environment.
• Solid understanding of essential document requirements and clinical trial documentation processes.
• Good knowledge of Good Clinical Practice (GCP) and applicable regulatory requirements and guidelines, including Health Canada and FDA regulations.
• Strong written and verbal English communication skills; French and English bilingualism or fluency in another European or Asian language is an asset.
• Strong proficiency in Microsoft Word, Excel, and PowerPoint.
• Excellent organizational and time-management skills, with the ability to prioritize multiple assignments and consistently meet deadlines.
• High attention to detail and a strong commitment to quality and accuracy.
• Strong communication, collaboration, problem-solving, and multitasking abilities.
• Ability to work independently, adapt quickly to changing priorities, and operate effectively in a fast-paced international environment.
• A proactive mindset, willingness to learn, and genuine interest in clinical research and project administration.

• Permanent, full-time employment.
• Flexible work schedule.
• Company benefits package.
• Ongoing learning, training, and professional development opportunities.
• Opportunities for career growth and advancement.
• Collaborative and stimulating international work environment.
• Opportunity to contribute to clinical trials with global impact.
• Eligibility is limited to candidates who are legally authorized to work in Europe.