Project Manager - Clinical Trial Services
As Novitan continues to grow its Clinical Trial Services offering, we are seeking an experienced Project Manager to take ownership of client projects from set-up through to completion. You will act as the primary point of contact for assigned clients, coordinating internal teams, external vendors, logistics partners, and client stakeholders to ensure every project is delivered on time, to the highest quality standards, and within agreed commercial parameters.
The job
- Manage assigned clinical trial packaging and distribution projects, ensuring delivery against agreed timelines, budgets, quality standards, and client expectations.
- Serve as the primary point of contact for assigned clients, maintaining clear, professional, and timely communication throughout the project lifecycle.
- Coordinate project set-up activities, including establishing internal timelines, operational readiness, and project set-up in the ERP system.
- Lead the generation and review of project documentation, including clinical label design, packaging batch records, and distribution documentation.
- Monitor inventory levels, stock status, and expiry dates to ensure adequate supply is available for future production runs and ongoing distribution campaigns.
- Coordinate all distribution-related activities in line with client requirements and expectations.
- Work with IRT/RTSM systems to support inventory release and shipment status updates.
- Coordinate with the global depot network and logistics service providers to ensure compliant, on-time delivery of investigational medicinal products to trial sites worldwide.
- Ensure all project activities are performed in accordance with applicable SOPs, GMP/GDP requirements, quality standards, and agreed client processes.
- Support financial management of assigned projects, including quotation input, budget tracking, submission of invoicing details, and delivery within agreed budget parameters.
- Identify project risks, escalate concerns in a timely manner, and support mitigation planning with relevant internal and external stakeholders.
- Contribute to continuous improvement initiatives within Clinical Trial Services, including improvements to templates, processes, systems, documentation, and ways of working.
- Occasional travel may be required, and out-of-hours availability may be necessary to address critical project needs, client demands, or international logistics activities.
- Undertake other duties or projects as reasonably assigned by management.
Your profile
- Minimum of five years' experience in project management, pharmaceutical supply chain, clinical trial services, or a related regulated environment.
- Prior experience in clinical packaging, pharmaceuticals, medical devices, or a similar industry is strongly preferred.
- Experience working with clients, vendors, logistics providers, depots, or cross-functional operational teams is required.
- Experience with clinical trial packaging, labelling, IRT/RTSM systems, GMP documentation, or GDP distribution activities is advantageous.
- Working knowledge of EU GMP Annex 13 and EU GDP guidelines is advantageous.
- Strong communication, client management, and stakeholder engagement skills, with the ability to build effective working relationships across internal teams, clients, and external vendors.
- Ability to manage multiple projects, priorities, and client deliverables while maintaining high accuracy and attention to detail.
- Strong organisational, planning, and documentation skills with a structured and proactive approach to project delivery.
- A professional, customer-focused approach with a strong sense of accountability, ownership, and teamwork.
- Proficient in Microsoft Office (Word, Excel, PowerPoint).
- A degree in life sciences, pharmacy, engineering, supply chain, or business management is preferred. A recognised project management qualification (PMP or PRINCE2) or supply chain certification (APICS CSCP) is advantageous but not essential.
Our offer
- A dynamic and supportive work environment within a growing company.
- A modern, well-equipped office located in the Evolis Business Park in Kortrijk.
- Competitive compensation package.
- A challenging and engaging role that promotes a healthy work-life balance.
Apply via jobs@novitan.com