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:
1. Oversee clinical trial supply planning, procurement, and distribution.
2. Develop supply strategies.
Lead Comparator Sourcing & Vendor Management:
1. Lead comparator drug sourcing strategies; secure high-quality products at competitive prices.
2. Manage relationships with manufacturers, wholesalers, and distributors to ensure reliable supply.
3. Negotiate contracts and pricing agreements.
4. Ensure GDP compliance; verify product integrity through supplier qualification.
Manage Packaging and Labelling Coordination:
1. Oversee packaging and labelling operations; ensure compliance with cGMP and regulatory standards.
2. Coordinate with CMOs for blinding, over-labelling, and kit assembly.
3. Meet multilingual labelling requirements for global trials.
4. Manage randomization and kit allocation per study protocols.
Maintain Regulatory Compliance and Documentation:
1. Ensure activities comply with FDA, EMA, MHRA, and other guidelines.
2. Maintain records of batch releases, CoAs, and temperature logs.
3. Support audits and inspections.
Manage Logistics & Distribution:
1. Oversee global cold chain logistics and temperature-controlled shipments.
2. Work with 3PL providers, couriers, and depot networks.
3. Implement contingency plans for disruptions.
Cross-Functional Collaboration:
1. Partner with Clinical Operations, Regulatory, QA, and Procurement teams.
2. Provide project updates and KPI reports to management.
3. 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.
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