Global Clinical Trials Supply Chain Manager

4 days ago

Uxbridge, United Kingdom Cpl Life Sciences Full time
Job Title: Clinical Supply Chain Manager

Location: Remote

Pay Rate: Up to £52,343 Per Annum

Contract Duration: 12 Months – Flex to be extended/perm

About the Role

Cpl Life Sciences is seeking a highly skilled Clinical Supply Chain Manager to join our team. As a key member of our Global Clinical Supply Chain organization, you will play a critical role in ensuring the timely delivery of quality clinical supplies for our global portfolio of clinical studies.

Key Responsibilities
  • Create and maintain supply strategies for all investigational products based on scientific and regulatory requirements.
  • Collaborate with internal teams and external partners to ensure all needs are met.
  • Define, plan, and communicate clinical supply chain strategies to promote optimal use and alignment with study and corporate goals.
  • Identify and support strategies for continuous improvement, both departmental and inter-departmental.
  • Review and provide input to draft clinical protocols, communicate timelines and investigational product strategies to study and cross-functional teams.
  • Develop supply forecasts for studies through evaluation of the clinical development plan and protocol analysis.
  • Monitor inventory and analyze drug utilization versus forecast, taking into account country requirements and logistical timelines.
  • Issue 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 and support use date extension activities.
  • Ensure timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources.
  • Participate in development, review, and approval of Interactive Response Technology (IRT) specifications.
  • Develop investigational product distribution strategies and maintain distribution and supply strategies at depot and site level according to study and IRT requirements.
  • Actively participate in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, and Clinical Supply Matrix Team meetings.
  • Collaborate with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements.
  • Act 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.
  • Support associated actions stemming from change controls.
  • Prepare eTMF, CSR appendices, and batch listings to support inspection readiness activities.
  • Enter product complaints and deviations in appropriate system and work with PDQ for investigation and resolution.
  • Manage conflicts/issues with internal and external partners and customers.
  • Write departmental procedural documents as applicable.
Requirements
  • Minimum 2 years Pharma industry-related experience.
  • Minimum 1 year Clinical Supplies/Development with global experience or equivalent experience.
  • 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, 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.
  • Ability to build/drive internal team consensus.
  • Translates broad strategies into specific objectives and action plans.
  • Team and individual leadership (leads courageously).
  • Oral and written communication (fosters open communication).
  • Conflict resolution (manages disagreements).
  • Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).
  • Influencing (manages influencing others).
  • Coaching and mentoring (fosters teamwork).

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