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Clinical Trial Supply Project Manager

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Horsham

Hybrid

GBP 60,000 - 80,000

Full time

4 days ago
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Job summary

A leading company in the clinical trial supply sector is seeking a Clinical Trial Supply Project Manager. This role involves overseeing supply planning, vendor management, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in clinical trial supply management and strong project management skills.

Qualifications

  • 5+ years in clinical trial supply management.
  • Experience with biopharma sponsors, CROs, and CMOs.

Responsibilities

  • Oversee clinical trial supply planning, procurement, and distribution.
  • Manage relationships with manufacturers and distributors.

Skills

Project Management
Problem Solving
Communication

Education

Bachelor's in Life Sciences
Bachelor's in Pharmacy
Bachelor's in Supply Chain

Tools

Clinical Supply Software
IRT/RTSM
Inventory Tools

Job description

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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