Global Clinical Supply Project Lead

Uniphar Group; Maryland; On-site; USD 90,000 - 130,000; Full time

Job description

Overview

Lead the delivery of clinical trial supplies worldwide in a fast-paced international environment. This role combines project management, client communication, and operational coordination to ensure compliant and efficient execution from start to finish.

Responsibilities

• Act as primary client point of contact for assigned global clinical programs
• Manage projects from initial enquiry through execution and close-out (IMP, comparator sourcing, packaging, labelling, storage, distribution)
• Review and understand client protocols and requirements and convert into clear operational instructions for internal stakeholders
• Define scope, timelines, deliverables, and budgets
• Facilitate and lead meetings with clients and internal stakeholders
• Plan and track project timelines, highlighting any potential delays, and provide mitigation options as appropriate
• Coordinate creation, review and approval of label text, artwork and regulatory compliant content
• Oversee packaging design (finished subject kit), component selection, label generation, printing, and application in accordance with GMP and country specifications regulations
• Create batch records associated with customer packaging / labelling 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, distribution of Clinical Trial Supplies globally
• Support the Quality function in audits (Regulatory, internal, or Client led)
• Collaborate with Quality to investigate and resolve deviations, and implement effective CAPAs
• Identify and manage preferred suppliers (e.g., label, carton, shipping material suppliers) to support the business
• Collaborate with other customer vendors in the delivery of the Clinical Trial
• Manage returns and destruction processes for used and unused product
• Train and mentor other staff in packaging, labelling, and distribution activities
• Understand current and updated regulatory requirements related to packaging, labelling, and distribution of Clinical Trial Supplies
• Maintain a strong safety culture through training and proactive risk mitigation; ensure Right First Time (RFT) approach

Qualifications

• Strong project management and organizational skills
• Commercially focused while maintaining high levels of customer service and quality
• Solution-oriented mindset with 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

Required Knowledge and Experience

• Bachelor’s degree or equivalent in life sciences, supply chain or extensive experience in a similar role
• Minimum of 2 years of industry experience, preferably within pharmaceuticals or clinical supplies
• Knowledge of GMP, ICH guidelines, EudraLex Vol. 4 with emphasis on Annex 13 (Investigational Products)
• Understanding of blinding requirements for randomized placebo-controlled clinical trials
• Familiarity with regulatory and quality standards for production, labelling, and distribution of Investigational Medicinal Products
• Working knowledge of inventory management and control through an ERP system
• Understanding of IRT / RTSM systems

Benefits

• Exclusive onboarding box with unique items
• Competitive salary with extensive fringe benefits
• Company laptop and phone
• Excellent pension scheme
• Fresh fruit at work
• Opportunity for training and personal/job development
• Career opportunities within Uniphar Global Sourcing and related entities
• Collaborative and enthusiastic team environment