FSP Clinical Supplies Project Manager (CTSM)
About The Position
The Clinical Trial Site Manager (CTSM), also known as the Clinical Supplies Project Manager, is the single point of contact for the study team, including Central and Local teams. The role is accountable for setting up and following logistical activities from initiation of a draft concept protocol through product delivery to the final depot. This includes translating study protocols into operational demand, assessing logistical feasibility, defining supply, distribution, and randomization strategies, and setting up and following clinical supply activities for a project or group of studies. The CTSM aligns stakeholders, GMP operations, and Central and Local clinical operations to support timely, quality delivery of clinical vaccines and ancillaries within the agreed budget. The position includes project management, leadership, and oversight of global and in-country activities, as well as authorship of some study documents. The CTSM coordinates clinical supply interfaces and study logistics, manages study setup and continuity, monitors milestones and KPIs, and supports standard processes, documentation, and inspection readiness.
Requirements
- Bachelor’s degree required.
- No prior project management or coordination experience required.
- Strong proficiency in Microsoft Office, particularly Excel, PowerPoint, and Project.
- Excellent organizational and time-management skills, including the ability to handle multiple projects simultaneously.
- Outstanding written and verbal communication skills.
- Detail-oriented, with strong documentation and process-management capabilities.
- Ability to work independently and collaborate effectively with cross-functional teams.
- Strong analytical and problem-solving skills.
- English proficiency required; additional languages may be needed depending on location.
- Experience with project management software and tools.
- Ability to identify and mitigate risks while maintaining project timelines.
- Strong customer-service orientation and interpersonal skills.
- Flexibility to adapt to changing priorities and deadlines.
- Understanding of relevant industry regulations and standards.
Nice To Haves
- Preferred fields of study include Chemistry, Biology, Engineering, Business, or a related discipline.
- Project management certifications are valued but not required.
- Experience with quality systems and GMP compliance preferred.
- Experience in pharmaceutical, healthcare, or scientific industries preferred.
Responsibilities
- Serve as the effective interface between Clinical Supply Chain (CSC) and Clinical Study Teams, including study delivery, local delivery, labeling, packaging, depot, distribution, and quality partners.
- Represent Clinical Study Team needs and constraints within CSC regarding logistical supply management and support.
- Provide input into study protocols and related documents.
- Assess operational feasibility for new study protocols and escalate feasibility issues to the Clinical Study Team, Clinical Supply Operations, and Portfolio Manager.
- Report planned studies and new demand in ongoing studies to the planning team for capacity feasibility assessment.
- Define each study’s operational setup, align flows, strategies, and activities, and develop a logistical plan with a detailed schedule and budget.
- Own supply chain processes and documents, and ensure study-related activities are set up and conducted in CSC in accordance with the approach agreed with the study team.
- Set up and manage collaboration with worldwide depots according to local requirements in participating countries.
- Follow up on studies and ensure continuity by arranging vaccine resupplies in time according to recruitment strategies and changing study and country needs.
- Ensure Clinical Supply Operations respects study milestones based on planning information from the Production Planner.
- Serve as the single point of contact for reviewing study timelines and renegotiating due dates.
- Monitor study KPIs, identify trends, and ensure problems are addressed.
- Act as a subject matter expert for one or more team processes and ensure standard processes and ways of working are followed across projects and studies.
- Develop and maintain SOPs, wiki content, guidance, and training materials for logistical processes, study management, and stakeholder interfaces.
- Ensure inspection readiness, including documentation of relevant communications and strategic decisions in eTMF/Veeva.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
