Clinical Trial Supply Manager
Place in the Organization
The Clinical Trial Supply Manager will be part of a team based in Amsterdam, reporting to the Head of Supply Chain. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization. The position requires enthusiasm, passion, influence, attention to detail.
Job Summary
The Clinical Trial Supply Manager will be responsible for ensuring the clinical supplies needed for clinical studies are provided on time and in accordance with protocol and applicable regulatory requirements. This includes management and oversight of the planning, forecasting, sourcing, packaging, labelling, distribution and return of clinical supplies
Key result areas (major duties, accountabilities and responsibilities)
- Develop study specific Investigational Product Supply Plans and contribute to Pharmacy Manuals and supply related training/instructional materials
- Manage supply planning/forecasting to ensure alignment with study activity and timelines
- Monitor inventory levels through the life of a trial proactively avoiding potential issues
- Collaborate with CMC, study team and vendors to assure proper distribution of supplies to study sites
- Serve as primary point of contact for third party packaging, distribution, and storage vendors
- Manage approval of the packaging and logistics service agreements and study specific plans
- Design/review/coordinate approval of investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements
- Bachelor’s degree, preferably in Supply Chain/Logistics, Engineering, Business, Economics, Sciences, or equivalent in related specific experience
- 6+ years of relevant experience in the biotech, pharmaceutical, or medical device industry, in supply chain
- Experience in clinical/commercial stage GMP environments in supply chain, with a Quality mindset and comfort and expertise in GMP expectations in supply chain and manufacturing.
- Experience working closely with Manufacturing, Project Management, functional team leaders and clinical teams, and adaptable to needs of uniQure’s organization and platforms.
- Excellent MS Office skills, and advanced analytical skills, with attention to detail
- Experience with industry standard processes and enterprise and requirements planning systems build around robust processes
- Additional specific qualifications in the area of supplies demand and logistics/ or planning management including and APICs, CPIM, and related professional certifications preferred.
- Knowledge or Training and experiences with LEAN / Continuous Improvement methodologies
- Excellent interpersonal, verbal, and written communication skills
- Self-motivated, willing to learn and improve, build trust easily and operate with integrity and ethics in a cGMP organization
- Good documentation practices in cGMP and SOX compliant environments
- Ability to effectively plan, prioritize, execute, follow up and anticipate challenges
- Experience managing complex schedules and priorities in dynamic environments with keen attention to details
- Ability to work, influence, and gain consensus across multiple functions
- Strong analytical, problem solving and critical thinking skills and strong written and communication skills
- Ability to balance work independently and as a team player with a positive and professional attitude
- Willingness and the ability to learn new skills