Clinical Supply Project Manager

Uniphar Group; Lelystad; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Onboarding box

Company events

Competitive salary + benefits

Laptop and phone

Pension plan

Fresh fruit at work

Training opportunities

Career growth

Fun team

Job summary

Uniphar is seeking a Clinical Supply Project Manager to lead worldwide delivery of clinical trial supplies from a fast-paced, international hub. You will blend project management, client communication, and operational coordination to ensure compliant execution from enquiry to close-out.

The role requires strong PM skills and experience in GMP/ICH contexts. Workload is distributed across multiple projects in a dynamic team; expect growth opportunities and a competitive benefits package.

Qualifications

• Bachelor’s degree or equivalent in life sciences, supply chain or extensive experience in a similar role.
• Minimum of 2 year of industry experience, preferably within pharmaceuticals or clinical supplies.
• Knowledge of GMP, ICH guidelines, EudraLex Vol. 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 the regulatory and quality standards associated with production, labelling, and distribution of Investigational Medicinal Products.
• A working knowledge of inventory management and control through an ERP system.
• An understanding of IRT / RTSM systems.

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 providing 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 any required audits (Regulatory, internal, or Client led)
• Collaborate with the Quality function to investigate and resolve deviations, manage implementation of effective corrective and preventative actions (CAPA’s)
• Identify and manage preferred suppliers to support the business e.g. label suppliers, carton suppliers, shipping material suppliers, and other.
• 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 un-blinded point of contact within Uniphar Clinical
• Train and mentor other staff in the execution of 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.

Skills

Project management

Communication

Attention to detail

Multi-project management

Education

Bachelor’s degree in life sciences or related field

Tools

ERP system

IRT/RTSM systems

Job description

Clinical Supply Project Manager

32-40 hours

Join a fast-paced international environment where you will lead the delivery of clinical trial supplies worldwide. In this role, you will combine project management, client communication, and operational coordination to ensure compliant and efficient execution from start to finish.

We are Uniphar | Clinical

Uniphar Clinical is a global clinical supply partner providing end-to-end solutions for pharmaceutical, biotech, and medical device companies, including commercial drug sourcing, clinical packaging and labeling, global storage and distribution, and overage management. Part of the Uniphar Group, it offers reliable, regulatory-compliant solutions to accelerate clinical trials.

Part of Uniphar | Global Sourcing

Uniphar | Global Sourcing is the global sourcing business of Uniphar Pharma, providing compliant, end-to- end supply and distribution solutions for pharmaceuticals and medical products. With a global footprint and local expertise, we ensure fast, reliable, and ethical access to essential healthcare products across more than 180 countries.

We support manufacturers, healthcare providers, and public health organizations through agile logistics, regulatory strength, and customized solutions tailored to complex international needs – with the mission to make medicines globally available, accessible, and affordable.

This is what you will do

• 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 providing 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 any required audits (Regulatory, internal, or Client led)
• Collaborate with the Quality function to investigate and resolve deviations, manage implementation of effective corrective and preventative actions (CAPA’s)
• Identify and manage preferred suppliers to support the business e.g. label suppliers, carton suppliers, shipping material suppliers, and other.
• 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 un-blinded point of contact within Uniphar Clinical
• Train and mentor other staff in the execution of 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.

This is you!

• Strong project management and organizational skills
• Commercially focused whilst maintaining highest levels of customer service and quality
• 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 details
• Ability to manage multiple projects simultaneously in a fast-paced environment

What to bring

• Bachelor’s degree or equivalent in life sciences, supply chain or extensive experience in a similar role
• Minimum of 2 year of industry experience, preferably within pharmaceuticals or clinical supplies.
• Knowledge of GMP, ICH guidelines, EudraLex Vol. 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 the regulatory and quality standards associated with production, labelling, and distribution of Investigational Medicinal Products.
• A working knowledge of inventory management and control through an ERP system
• An understanding of IRT / RTSM systems

For you, from Uniphar | Global Sourcing

• An exclusive onboarding box with unique items;
• Cool company parties/outings (check them out on our LinkedIn or Facebook page);
• A competitive salary with extensive fringe benefits;
• Company laptop and phone;
• Excellent pension scheme;
• Fresh fruit at work;
• Opportunity to follow training and courses in the context of personal development and/or job-related;
• Many career opportunities within the BModesto Group and the various entities;
• Lots of fun every day in an enthusiastic team with adventurous and razor-sharp colleagues.

Do you have any questions about the vacancy? Do not hesitate to contact our HR department by calling [phone] or emailing [e-mail].