Clinical Trial Supply Project Manager

Are you looking for that perfect role which combines your pharmaceutical products knowledge with your experience in regulatory-compliant delivery? Are you a self-starter, always looking to improve processes and help as needed? Do you have that entrepreneurial spirit that will be recognized in a growing organization? Do you act with integrity and positive energy? Our client, Clinical Services International, the trusted global leader in the supply of comparator drugs, medical devices and ancillaries for clinical trials, is looking for a Clinical Trial Supply Project Manager in the suburban Philadelphia area!

Highlights

• Contribute to a fast-growing company with a 'can do' culture where you will be encouraged to get involved in a range of exciting initiatives and to introduce new ideas.
• Collaborate with us to continue growing our company within the pharmaceutical industry.Visit us at www.csint.com for more information about who we are and how we contribute in the clinical trial market.
• Flexible work location including onsite (state-of-the-art facility in Horsham, PA) or hybrid. Willingness to be in our Horsham, PA facility 2-3 days per week.

How You’ll Contribute

Play a key role in project management and strategy

• Oversee the clinical trial supply planning, procurement, and distribution process
• Develop supply strategies
• Work with sponsors, CROs, CMOs, and vendors to maintain supply chain
• Identify risks and develop mitigation plans to prevent supply disruptions

Lead Comparator Sourcing & Vendor Management

• Lead comparator drug sourcing strategies; secure high-quality products at competitive prices
• Manage relationships with pharmaceutical manufacturers, wholesalers, and distributors to ensure reliable supply
• Negotiate contracts and pricing agreements with suppliers
• Ensure GDP (Good Distribution Practice) compliance; verify product integrity through supplier qualification processes

Manage the Packaging and Labelling Coordination

• Oversee clinical trial packaging and labelling operations; ensure compliance with cGMP (Current Good Manufacturing Practices), regulatory standards
• Work with CMOs (Contract Manufacturing Organizations) to coordinate blinding, over-labelling, and kit assembly Work with sponsors, CROs, CMOs, and vendors to maintain supply chain
• Ensure multilingual labelling requirements are met for global trials
• Manage randomization and kit allocation in alignment with study protocols

Maintain Regulatory Compliance and Documentation

• Ensure all supply chain activities comply with FDA, EMA, MHRA, and other global regulatory guidelines
• Maintain detailed records of batch releases, CoAs (Certificates of Analysis), and temperature logs
• Support audits and inspections by regulatory authorities and sponsors
• Ensure GDP (Good Distribution Practice) compliance; verify product integrity through supplier qualification processes

Manage Logistics & Distribution

• Oversee global cold chain logistics and temperature-controlled shipments
• Work closely with 3PL providers, couriers, and depot networks to optimize trial supply distribution
• Implement supply chain contingency plans for potential disruptions

Cross-Functional Collaboration

• Partner with Clinical Operations, Regulatory Affairs, Quality Assurance, and Procurement teams to align supply strategies with trial objectives
• Provide regular project updates and KPI reports to senior management
• Train internal teams on supply chain best practices and regulatory requirements

About YOU!

• 5+ years’ experience in clinical trial supply management with a focus on comparator sourcing, packaging and labelling
• Bachelor’s degree in Life Sciences, Pharmacy, Supply Chain Management or a related field.
• Experience working with biopharmaceutical sponsors, CRO’s and CMO’s
• Strong understanding of GDP, cGMP, ICH-GCP and regulatory guidelines
• Experience with clinical supply chain software, IRT/RTSM systems and inventory tracking tools.
• Proficiency in vendor contract negotiations and budget management
• Knowledge of temperature-controlled supply chain logistics
• Excellent project management, problem solving and decision-making skills. APIcs, PMP or Six Sigma certification in supply chain management preferred
• Experience managing global clinical trails and multi-region supply strategies preferred
• Familiarity with EU Qualified Person (QP release processes preferred)
• Ability to manage multiple stakeholders and deadlines effectively
• Strong written and verbal communication skills
• Hybrid work flexibility available with occasional travel

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