FSP Clinical Supplies Project Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as the primary contact for the study team, which includes Central and Local Operating Companies.

• Organize and monitor logistical activities from the initiation of the draft concept protocol through to product delivery at the final depot.

• Convert study protocols into operational requirements and evaluate logistical feasibility.

• Establish logistics operational strategies that encompass supply, distribution, and randomization.

• Organize and monitor clinical supply activities for specific projects or groups of studies.

• Coordinate stakeholders, GMP operations, and clinical operations to ensure timely delivery of clinical vaccines and ancillaries, meeting required quality standards and budget constraints.

• Serve as a liaison between the Clinical Supply Chain and Clinical Study Teams, including delivery leads, labeling and packing specialists, depots, distribution experts, and quality partners.

• Contribute to study protocols and related documents while providing logistical guidance for investigational sites.

• Determine operational feasibility and escalate any feasibility concerns.

• Inform the planning team of upcoming studies and new demands for capacity evaluation.

• Specify the operational setup for studies, logistical plans, detailed schedules, and budgets.

• Oversee supply chain processes and documentation to ensure that study activities are operationally established and executed as planned.

• Manage collaboration with global depots in accordance with local country requirements.

• Ensure timely resupply of vaccines based on recruitment strategies and the evolving needs of studies and countries.

• Ensure that study milestones are achieved and renegotiate deadlines when necessary.

• Monitor study KPIs, identify trends, and address any issues that arise.

• Serve as a Subject Matter Expert for one or more team processes and standardize operational procedures.

• Create and maintain SOPs, wiki content, guidance documents, and training materials.

• Maintain readiness for inspections and document significant communications and strategic decisions in eTMF/Veeva.

⛳️ Requirements

• A Bachelor's Degree is required; no prior experience in project management or coordination is necessary.

• Preferred fields of study include Chemistry, Biology, Engineering, Business, or a related discipline.

• Additional certifications in Project Management are appreciated but not mandatory.

• Strong proficiency in Microsoft Office Suite, especially Excel, PowerPoint, and Project.

• Excellent organizational and time management abilities, with the capacity to manage multiple projects simultaneously.

• Exceptional written and verbal communication skills.

• Detail-oriented with robust documentation and process management skills.

• Experience with quality systems and GMP compliance is preferred.

• Ability to work independently while effectively collaborating with cross-functional teams.

• Strong analytical and problem-solving capabilities.

• Proficiency in English is required; additional languages may be advantageous based on location.

• Familiarity with project management software and tools.

• Ability to identify and mitigate risks while adhering to project timelines.

• Strong customer service orientation coupled with excellent interpersonal skills.

• Flexibility to adjust to changing priorities and deadlines.

• Understanding of relevant industry regulations and standards.

• Experience in the pharmaceutical, healthcare, or scientific sectors is preferred.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.