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Our client is a life science company searching for an experienced individual for a highly visible role as Senior Manager, Clinical Supply Chain. This person will support the delivery of investigational drug supplies for global clinical trials. She/he will collaborate on all aspects of clinical supply management including forecasting, labeling, distribution, monitoring inventory and IRT vendor oversight.

Responsibilities: 

• Support activities to deliver Clinical Trial Materials (CTM) in support of clinical activity by working closely with other members of CSC and CMC/Manufacturing to develop strategies to support clinical plans that ensure sufficient drug products to meet all supply chain requirements.
• Collaborate with Clinical Operations team to communicate CTM options for supply scenarios to meet clinical plans for existing and future studies.
• Collaborate in the development of forecasts for clinical supply demand from information beginning at protocol development and continuing with updates from Clinical Operations.
• Monitor key project milestones; communicating clinical supply plan timelines to internal and external stakeholders, to ensure on-time and on-budget delivery of CTM to clinical sites. Proactively identify risks and escalate when appropriate.
• Monitor lot genealogy to ensure all CTM clinical labeling production to upstream activities.
• Manage clinical supply planning process from inventory movement between vendors or depots, including extension of shelf-life, and adjusting allocations when necessary
• Collaborate in the development and approval of clinical labels with other functional areas such as CMC/Manufacturing, Clinical Operations, QA, Regulatory and external vendors.
• Review and approve pre and post-production documentation of clinical supplies (including but not limited to label creation, generation of packaging requests, batch record review, and coordination of documentation with internal and external QA for release of CTM)
• Participate in the development of Interactive Response Technology (IRT) systems including IRT specification, user acceptance testing, production release, and identification of updates required to support randomization of participants.
• Monitor IRT activity to ensure agreement of CTM inventory between IRT and CMO throughout the distribution network across all studies. Identify and resolve discrepancies between the two systems. Develop work instructions, when appropriate, for capturing actions and setting to maintain continuity and consistency.
• Collaborate on pharmacy manuals, IRT reference documents and any other documents relevant to management of CTM with Clinical Operations and Quality Management
• Serve as point of contact for clinical team in the assessment of temperature excursions and investigation of product complaints.
• Support Quality Management in provision of required documentation for QP release.
• Other duties as assigned

Qualifications:

• Bachelor’s degree with more than 5 years of experience in clinical supply chain in a biotech or pharmaceutical environment
• Experience in CTM planning and execution for global clinical trials
• Experience in managing IRT vendors, from system design through production and maintenance activities
• Experience in operating in an cGMP environment
• Strong technical/analytical skills to identify and solve problems.
• Excellent organizational, interpersonal and communication skills