Clinical Supply Project Manager

32-40 hours

Join a fast-paced international environment where you will lead the delivery of clinical trial supplies 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 (CAPAs)
• 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

• Bachelors 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 recognize yourself in this profile Send your CV and cover letter and who knows you might come and meet us!

Do you have any questions about the vacancy Do not hesitate to contact our HR department by callingor emailing