Job title: Global Clinical Trials Supply Chain Manager at Cpl Life Sciences
Company: Clinical Professionals
Job description: Reference Number: JO-2409-540063
Global Clinical Trials Supply Chain Manager
Rate: Negotiable
Job Type: Contract
Location: Uxbridge
Pay Rate: Up to £52,343 Per Annum
Contract Duration: 12 Months – Flex to be extended/perm
Position Summary
Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision.
Roles and Responsibilities
* 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.
* 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.
* Develops supply forecasts for studies through evaluation of the clinical development plan and protocol analysis.
* Issues Manufacturing and Packaging/Labelling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines.
* Monitor use date of investigational drug product for assigned protocols.
* Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols.
* Participates in development, review and approval of Interactive Response Technology (IRT) specifications.
* Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings.
* Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements.
* Acts as the main Clinical Supplies contact person for the assigned compound and associated studies.
* Supports associated actions stemming from change controls.
* In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings.
* Enters product complaints and deviations in appropriate system.
* Manages conflicts/issues with internal and external partners and customers.
* Writing of departmental procedural documents as applicable.
* Performs other tasks as assigned.
Skills and Qualifications
* Minimum 2 years Pharma industry related experience.
* Minimum 1 years Clinical Supplies/Development with global experience or equivalent experience.
* Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
* Proficient and strong analytical skills.
* Strong communication and negotiation skills.
* Proficient and strong Project management skills.
* Strong knowledge of Forecasting and Planning and proficient knowledge of related areas.
* Proficient knowledge of import / export requirements.
* Proficient/Strong knowledge of IVRS and CTMS systems.
* Ability to build/drive internal team consensus.
* Translates broad strategies into specific objectives and action plans.
* Team and individual leadership.
* Oral and written communication.
* Conflict resolution.
* Negotiation.
* Influencing.
* Coaching and mentoring.
Expected salary:
Location: United Kingdom
Job posting date: Wed, 04 Sep 2024 22:11:17 GMT
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