Clinical Supply Project Manager

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

Benefits offered by this job

Company laptop and phone

Excellent pension scheme

Fresh fruit at work

Career opportunities within Uniphar

Job summary

Uniphar Group in Maryland seeks a lead to guide the end-to-end delivery of clinical trial supplies across global programs. You will coordinate packaging, labeling, storage, and distribution activities with clients and internal teams to ensure compliant execution.

You will define scope, timelines, and budgets, facilitate meetings, monitor risk, and uphold GMP/ICH standards for safe, on-time delivery of Investigational Medicinal Products worldwide.

Qualifications

• Strong project management and organizational skills.
• Commercially focused while maintaining high levels of customer service and quality.
• Solution-oriented with ability to anticipate risks and propose mitigations.

Responsibilities

• Act as primary client point of contact for assigned global clinical programs.
• Manage projects from enquiry through execution and close-out (IMP, comparator sourcing, packaging, labelling, storage, distribution).
• Review client protocols and convert requirements into operational instructions.
• Define scope, timelines, deliverables, and budgets.
• Lead meetings with clients and internal stakeholders.
• Plan and track project timelines, flag delays, and propose mitigations.
• Coordinate label text, artwork and regulatory content approval.
• Oversee packaging design, component selection, labeling, and application per GMP/regulations.
• Create batch records for packaging/labeling activities.
• Oversee manufacturing operations to meet client delivery timelines and quality standards.
• Ensure documentation for processing, release, export/import, distribution of Investigational Medicinal Products.
• Support Quality in audits and CAPA implementation.
• Identify and manage preferred suppliers for packaging materials.
• Collaborate with other vendors to deliver the Clinical Trial.
• Manage returns and destruction for used/unused product.
• Train and mentor staff in packaging, labeling, and distribution.
• Understand current regulatory requirements for packaging, labeling, and distribution.
• Maintain safety culture and Right First Time approach.

Skills

Project management

Communication

Attention to detail

Multi-project coordination

Customer service orientation

Education

Bachelor’s degree or equivalent in life sciences/supply chain

Tools

ERP system

GMP/ICH knowledge

IRT/RTSM systems

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