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Global Clinical Supply Lead

SRG
Fort Collins, CO
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Global Clinical Supply Lead

 

Summary:

 

Here at SRG, we are looking for an experienced Global Clinical Supply Lead for one of our top clients. The CMC team operates an internal and semi-virtual model. Our client’s goal is to develop of exciting new products in the field of addiction therapy and associated co-morbidities from Phase 1 clinical trials through to commercialization. The product / project portfolio includes the formulation of controlled pharmaceutical ingredients requiring special consideration in relation to handling and movement.

 

Key Responsibilities:

  • Be an active member of the Clinical Study Protocol development teams:
  • Interpret clinical trial protocols for the study drug requirements (Investigational and commercially sourced) for the proposed study design.
  • Ensure the feasibility of study drug required for the study design is appropriate.
  • Understand the requirements for packaging and labelling.
  • Ensure all labelling regulations are met for countries involved.
  • Manage the coordination between Global Medicines Development (GMD), R&D CMC/Commercial Supply and Quality Assurance (QA) to deliver the IMP to support study timelines.
  • Advise on clinical site logistics and handling including storage conditions and required capacities, as applicable.
  • Provide content for study related documents for study drugs; for example, pharmacy manuals, training slides for Investigator meetings, site initiation visits, etc.

Management of Manufacturing, Packaging and labelling:

  • Manage the acquisition of any required commercial sourced Study Drug.
  • Manages the logistic activities of global project(s) clinical supply chain including initiating and managing all GMP bulk shipments across the supply chain (API, DP, FG).
  • Ensure all Clinical study drug supplies are manufactured (in coordination with Commercial Supply team, as needed) and COA meets all the applicable regulations for the country of the clinical study in coordination with QA/QP release.
  • Ensure sufficient supply of study drug is available to supply all clinical study timelines.
  • Engage and manage appropriate 3rd parties (in coordination with commercial supply, as needed) as necessary to perform GMP clinical drug assembly labelling and release.

Clinical Trial Supply Management:

  • Manage the shipments to and from the Warehouse to clinical site(s), if applicable.
  • Be point of contact for the Warehouse / clinical sites for IMP supply / re-supply.
  • Ensure all shipments are delivered on-time, intact and within temperature range or coordinate with QA to ensure any temperature excursions are acceptable or required remedial action is taken.
  • Liaise with QA on reported study drug product complaints to ensure the required documentation is provided to the CDM for inclusion in the TMF.
  • Ensure expiry extensions are provided to the warehouse / clinical site, as needed to support use of Study Drug.
  • Oversee and manage the end of study drug reconciliation process, including managing the shipment and destruction of un-used study drug at either the Warehouse or our client in collaboration with the CPM and CRO, drug depot IVRS vendor management, as applicable.
  • Submit and be responsible for ensuring all IMP distribution/reconciliation and associated documents are submitted to the TMF folders.
  • Ensure internal and GCP audit readiness for clinical trial supply documentation in all areas related to clinical supply chain management.

Qualifications for the Global Supply Lead Role:

  • A degree in Science or other relevant discipline.
  •  5+ years’ experience in pharmaceutical drug development.
  •  Strong understanding of global pharmaceutical regulations.
  •  Experience of understanding and interpretation of clinical study design and the ability to translate this into a well-planned, accurately forecasted clinical trial supply plan.
Company Description
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRG

Why Work Here?
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SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

Address

Fort Collins, CO
USA

Industry

Healthcare

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