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Uniphar

Outsourced pharmaceutical, medtech, and supply-chain services

Clinical Supply Project Manager

Project ManagementConfirmed live in the last 24 hours
Full-timeLelystad, NetherlandsNo salary listedIn-person

About the Job

Requirements

  • Strong project management and organizational skills.
  • A commercially focused approach while maintaining high levels of customer service and quality.
  • A solution-oriented mindset with the ability to anticipate risks and propose mitigations.
  • Excellent communication skills for cross-functional coordination.
  • Ability to interpret clinical protocols and regulatory requirements related to packaging and labeling.
  • High attention to detail.
  • Ability to manage multiple projects simultaneously in a fast-paced environment.
  • Bachelor’s degree or equivalent in life sciences or supply chain, or extensive experience in a similar role.
  • Minimum of 2 years of industry experience, preferably within pharmaceuticals or clinical supplies.
  • Knowledge of Good Manufacturing Practice (GMP), International Council for Harmonisation (ICH) guidelines, and EudraLex Volume 4, with specific emphasis on Annex 13 (Investigational Products).
  • In-depth understanding of blinding requirements for randomized placebo-controlled clinical trials and the ability to apply this knowledge in the workplace.
  • Familiarity with regulatory and quality standards associated with production, labeling, and distribution of Investigational Medicinal Products.
  • Working knowledge of inventory management and control through an enterprise resource planning (ERP) system.
  • Understanding of Interactive Response Technology (IRT) or Randomization and Trial Supply Management (RTSM) systems.

Responsibilities

  • Act as the primary client point of contact for assigned global clinical programs.
  • Manage projects from initial enquiry through execution and close-out, including Investigational Medicinal Product (IMP) and comparator sourcing, packaging, labeling, storage, and distribution.
  • Review and understand client protocols and requirements, and convert them into clear operational instructions for internal stakeholders.
  • Define project scope, timelines, deliverables, and budgets.
  • Facilitate and lead meetings with clients and internal stakeholders.
  • Plan and track project timelines, highlight potential delays, and provide mitigation options as appropriate.
  • Coordinate creation, review, and approval of label text, artwork, and regulatory-compliant content.
  • Oversee packaging design for finished subject kits, component selection, label generation, printing, and application in accordance with Good Manufacturing Practice and country-specific regulations.
  • Create batch records associated with customer packaging and labeling activities.
  • Oversee manufacturing operations to ensure client delivery timelines, quality standards, and safety requirements are consistently met.
  • Ensure relevant documentation is obtained for processing, release, exporting, importing, and distribution of clinical trial supplies globally.
  • Support the Quality function in required regulatory, internal, or client-led audits.
  • Collaborate with the Quality function to investigate and resolve deviations and manage implementation of effective corrective and preventive actions (CAPA).
  • Identify and manage preferred suppliers, including label, carton, shipping material, and other suppliers.
  • Collaborate with other customer vendors in delivery of the clinical trial.
  • Manage the returns and destruction process for used and unused product.
  • Act as the unblinded point of contact within Uniphar Clinical.
  • Train and mentor other staff in packaging, labeling, and distribution activities.
  • Understand current and updated regulatory requirements related to packaging, labeling, and distribution of clinical trial supplies.
  • Maintain a strong safety culture through training and proactive risk mitigation, and ensure a Right First Time (RFT) approach.

About the Company

Uniphar

Outsourced pharmaceutical, medtech, and supply-chain services

Uniphar is a diversified healthcare services provider offering outsourced services to pharmaceutical, medtech, and biotech manufacturers across three divisions: Uniphar Pharma, Uniphar Medtech, and Uniphar Supply Chain + Retail. Uniphar Pharma covers the drug lifecycle from development to commercialization, including sourcing hard-to-find medicines and supporting biotech launches globally. Uniphar Medtech provides outsourced sales, marketing, and distribution for medical devices; Supply Chain + Retail handles pre-wholesale/wholesale distribution and runs pharmacy brands like Allcare, Hickey's, and McCauley. It competes by leveraging a global infrastructure, a diversified services portfolio, and growth through acquisitions and high-tech distribution hubs to reach patients in over 180 countries and streamline supply chains so medicines are more accessible worldwide.

Company size
501-1,000
Company stage
IPO
Headquarters
Dublin, Ireland
Founded
1994

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