Clinical Supplies
JOB_53170854687176Job type
ContractLocation
LondonWorking Pattern
Full-timeSpecialism
Clinical ResearchIndustry
Scientific and R&DPay
Hourly rate
Ex Clin Supplies Spec - 6-month contract
Immediately available 6-month rolling contract for an experienced Clinical Supplies specialist, remote (1 - 2 days in the office a month)
Responsibilities
Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision.
• Collaborates with internal Global Clinical Supply Chain (GCSC) teams and external Customers and Service Providers, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors and Medical to ensure all needs are met.
• Proactively defines, plans, and communicates the clinical supply chain strategy in support of global clinical studies to promote optimal use and alignment with study and corporate goals. Demonstrates strong knowledge of GCSC processes when presenting at cross-functional meetings.
• Responsible for identifying and supporting strategies for continuous improvement, both departmental and/or inter-departmental.
• Influences clinical and development timelines, study design and country selection. Directly responsible for reviewing and providing input to draft clinical protocols, communicating timelines and investigational product strategies to study and cross-functional teams.
• Develops supply forecasts for studies through evaluation of the clinical development plan and protocol analysis. Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines.
• Issues Manufacturing and Packaging/Labelling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with Clinical Development team, Chemistry, Manufacturing & Controls (CMC) team and CSO Packaging and Labelling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements.
• Monitor use date of investigational drug product for assigned protocols. Support use date extension activities, such as generation of Use Date Extension (UDE) memo, and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites.
• Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account country Regulatory and QP Release requirements.
• Participates in the development, review and approval of Interactive Response Technology (IRT) specifications. Develops investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements.
• Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings and any other relevant meetings, providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies.
• Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements. Attends meetings with vendors and generates purchase requisitions as needed. Actively supports the budget process by maintaining supply and demand estimates for assigned studies in Budget Tool and by regularly reviewing and updating against revised clinical plans.
• Acts as the main Clinical Supplies contact person for the assigned compound and associated studies, leading communications regarding global supply strategy with study team as appropriate.
• Supports associated actions stemming from change controls.
• In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings to support inspection readiness activities.
• Enters product complaints and deviations in appropriate system and works with PDQ for investigation and resolution.
• Manages conflicts/issues with internal and external partners and customers.
Skills and Qualifications
• Minimum Clinical Supplies/Development with global experience or equivalent experience.
• Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
• Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IVRS, Logistics, Quality, Stability, etc.
• Proficient knowledge of import / export requirements.
• Proficient/Strong knowledge of IVRS and CTMS systems.
• Proficient / Strong knowledge of industry technology.
• Applies and drives forecasting and planning activity as it relates to protocol.
Clinical SuppliesJOB_531708546871762025-05-142025-08-12
Talk to Claire Helliwell, the specialist consultant managing this position
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JOB_53170854687176