Interim Packaging Project Coordinator (Clinical Trials)

Your New Daily rate: up to £230 PAYE/£301 umbrella (inside IR35) *equivalent of up to £60k
Duration: 12-month Interim Role
Location: Hertfordshire
Working hours: 37.5 hours per week
Job posting ID: JP102598

Who you'll be working for: We've been partnered with this FTSE100 business for over 20 years successfully placing Interim candidates in procurement roles.

Interim Packaging Project Coordinator - What You'll be Doing:

The Clinical Supply Chain organisation is responsible for the timely provision of packed clinical supplies from internal operations in support of clinical studies across all the R&D pipeline (phases 1-4). External Packaging Operations, is responsible for managing the technical content and delivery of these activities from Third Party Contractors (TPCs). The team members role in External Packaging Operations is to:

• Provide project management of the technical content of work packages associated with allocated projects, in liaison with supply chain contacts in CSC (Clinical Interface), R&D Procurement, External Quality Assurance (EQA) and external TPC contacts.
• Input technical expertise and TPC oversight at all stages of the work packages.
• Work package scope: primary and secondary packaging, labelling and distribution activities, and associated supporting activities.
• Manage work packages requirements to secure delivery to agreed timelines for allocated projects.
• Provide technical input in scoping requirements for externalisation; liaise with internal stakeholders to assess timelines and resources required.
• Define technical requirements within technical documentation; facilitate materials delivery to TPCs; review and approve TPC batch documents and/or label texts; technical review of completed batch documentation.
• Liaise with TPCs to agree technical requirements, monitor progress and resolve issues; seek advice from other team members/line manager/EQA; feedback on progress to CSC (Clinical Interface) contacts.
• Use planning tools to keep progress on track; keep the team informed of project progress through regular project tracking meetings; liaise with business partner lines to manage/adjust timelines and priorities; escalate issues and concerns as they arise.
• Ensure all activities are delivered compliant to defined processes and GMP; concerns / risks are identified.
• Ensure appropriate and complete records arising through operational activities are maintained and TPCs in compliance with GMP and that meet data integrity standards.
• Maintain quantitative and performance metrics for projects managed.
• Support quality or safety investigations and internal or external agency audits, as required.
• Engage and assess supplier technical proposals against project requirements and make sourcing recommendations in alignment with procurement.
• Maintain good industry knowledge of PLD working practices / ways of working and awareness of key CMO capabilities.
• Represent the team in supplier BRMs (Business Review Meetings) and initiatives at supplier/CMO sites as required.
• Track and monitor External Packaging Operations and TPC performance to ensure operational commitments meet agreed timelines and quality KPIs.

Interim Packaging Project Coordinator - The Skills You'll Need to Succeed:

• Experience working in an R&D GMP environment.
• Experience working in an operational Packaging Labelling Distribution (PLD) role within Clinical Trial Supplies.
• Knowledge of Clinical Trial Supply CMOs and their capabilities
• Knowledge of the pharmaceutical and clinical development processes and their relationship to the clinical supplies delivery processes; aware of clinical supply GMP requirements and standards.
• Lean Sigma training / experience
• Project Management training / experience
• Experience demonstrating organizational and planning skills coupled with strong written and oral communication skills
• Demonstrated capability to work with aggressive and changing timelines and with limited information and without defined absolutes.
• Knowledge of the technical challenges with regards to investigational product packaging and labelling.
• Demonstrated experience working in a third party management / oversight role.

*Please note this Umbrella rate is the amount payable to the Umbrella company - this does not represent what you will actually receive from the Umbrella company.

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We would be grateful if you could send your CV as a Word document. If your application is successful, you will be contacted within 7 days. We regret that due to the high volume of applications we receive we cannot provide feedback on individual CVs. Please note that we can only consider candidates who are eligible to work in the UK and are able to provide relevant supporting documentation.

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