Job Description
Clinical Trial Supply Project Manager
Are you looking for a role that combines your pharmaceutical product knowledge with experience in regulatory-compliant delivery? Are you a self-starter, always seeking process improvements and willing to help? Do you possess an entrepreneurial spirit that will be valued in a growing organization? Do you act with integrity and positive energy? Our client, Clinical Services International, a trusted global leader in supplying comparator drugs, medical devices, and ancillaries for clinical trials, is seeking a Clinical Trial Supply Project Manager in the suburban Philadelphia area!
Highlights
- Contribute to a fast-growing company with a 'can do' culture, encouraging involvement in various initiatives and new ideas.
- Collaborate to grow our presence in the pharmaceutical industry. Visit www.csint.com for more information about our contributions to the clinical trial market.
- Flexible work location: onsite at our state-of-the-art facility in Horsham, PA, or hybrid. Willingness to be in Horsham 2-3 days per week.
How You'll Contribute
Play a key role in project management and strategy:
- Oversee clinical trial supply planning, procurement, and distribution.
- Develop supply strategies.
Lead Comparator Sourcing & Vendor Management:
- Lead comparator drug sourcing strategies; secure high-quality products at competitive prices.
- Manage relationships with manufacturers, wholesalers, and distributors to ensure reliable supply.
- Negotiate contracts and pricing agreements.
- Ensure GDP compliance; verify product integrity through supplier qualification.
Manage Packaging and Labelling Coordination:
- Oversee packaging and labelling operations; ensure compliance with cGMP and regulatory standards.
- Coordinate with CMOs for blinding, over-labelling, and kit assembly.
- Meet multilingual labelling requirements for global trials.
- Manage randomization and kit allocation per study protocols.
Maintain Regulatory Compliance and Documentation:
- Ensure activities comply with FDA, EMA, MHRA, and other guidelines.
- Maintain records of batch releases, CoAs, and temperature logs.
- Support audits and inspections.
Manage Logistics & Distribution:
- Oversee global cold chain logistics and temperature-controlled shipments.
- Work with 3PL providers, couriers, and depot networks.
- Implement contingency plans for disruptions.
Cross-Functional Collaboration:
- Partner with Clinical Operations, Regulatory, QA, and Procurement teams.
- Provide project updates and KPI reports to management.
- Train teams on supply chain practices and regulations.
About YOU!
- 5+ years in clinical trial supply management, focusing on comparator sourcing, packaging, and labelling.
- Bachelor's in Life Sciences, Pharmacy, Supply Chain, or related field.
- Experience with biopharma sponsors, CROs, and CMO's.
- Strong understanding of GDP, cGMP, ICH-GCP, and regulations.
- Experience with clinical supply software, IRT/RTSM, and inventory tools.
- Vendor contract negotiation and budget management skills.
- Knowledge of temperature-controlled logistics.
- Excellent project management, problem-solving, and decision-making skills; certifications like APIcs, PMP, or Six Sigma preferred.
- Experience managing global trials and multi-region strategies.
- Familiarity with EU QP release processes.
- Ability to manage multiple stakeholders and deadlines.
- Strong communication skills.
- Flexible hybrid or remote work with occasional travel.