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 through on logistical activities from initiation of a draft concept protocol through delivery of the product 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 monitoring clinical-supply activities for a project or group of studies. The CTSM aligns stakeholders, GMP operations, and central and local clinical operations to deliver clinical vaccines and ancillary products on time, at the required quality, and within the agreed budget. The role encompasses project management, leadership, and oversight of global and in-country activities, as well as authorship of some study documents.
Requirements
- Bachelor’s degree required.
- No prior project management or coordination experience required.
- Strong proficiency with Microsoft Office, particularly Excel, PowerPoint, and Project.
- Excellent organizational and time-management skills, including the ability to manage 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.
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.
- Experience in pharmaceutical, healthcare, or scientific industries.
- Understanding of relevant industry regulations and standards.
Responsibilities
- Ensure effective coordination between Clinical Supply Chain (CSC) and the Clinical Study Team, including relevant delivery leads, label and pack experts, depot and distribution experts, and quality partners.
- Provide input to study protocols, give investigational sites logistical instructions, and communicate logistical requirements, due dates, and supply issues.
- Represent Clinical Study Team needs and constraints to CSC regarding logistical supply management and support.
- Contribute to the development of study protocols and related documents.
- Assess operational feasibility for each new study protocol and escalate feasibility issues to the Clinical Study Team, Clinical Supply Operations, and Portfolio Manager.
- Report newly planned studies and new demand in ongoing studies to the planning team for capacity feasibility assessment.
- Define the operational setup for each study, align workflows, strategies, and activities, and develop the study logistics plan, detailed schedule, and budget.
- Own supply-chain processes and documents, and ensure study activities are set up and conducted in CSC according to the approach agreed with the study team.
- Set up collaboration with worldwide depots selected for each clinical study in accordance with local requirements in participating countries.
- Follow up on studies and maintain continuity by ensuring vaccine resupplies occur on time according to recruitment strategies and changing study and country needs.
- Ensure Clinical Supply Operations meets study milestones based on information from the Production Planner.
- Serve as the single point of contact for reviewing study timelines and renegotiating due dates when needed.
- Monitor study KPIs, identify trends, and ensure issues are addressed.
- Serve as a subject matter expert for one or more team processes and ensure standard processes and ways of working are in place across projects and studies.
- Develop and maintain SOPs, wiki content, guidance, and training materials related to logistics processes, study management, and stakeholder interfaces.
- Maintain inspection readiness, including documenting relevant communications and strategic decisions in eTMF/Veeva.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
