Clinical Supply Chain (CSC) Product Sourcing Coordinator & Trial Manager

Altran - Swiftwater, PA

Full-time
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Context of the Role

The Clinical Logistics Coordinator (CLC) will be responsible to translate the clinical protocol in the best clinical logistics supply chain for the Trial-related Material (TRM) and vaccine products.

  • S/he is responsible for overseeing and managing all logistics activities of assigned New Vaccines and Medical Affairs clinical projects within the Global Trial Operations Management (GTOM) Function
  • The CLC is accountable for the supply strategy to the investigational sites of any Trial Related Material (TRM) that includes sample collection items, subject safety items, devices, equipment and documents. S/he is accountable for the coordination of all samples transportations to Labs.
  • S/he is accountable for the management of the product shipments, returns, destructions and reconciliation with accurate IRT IP management module configuration.
  • She/he partners with co-workers (GTOM, RTM, GCI, CSC, Procurement, CPMO…), external providers (External Vendors) and Client’s CSO/CSUs, to ensure clinical project delivery according to defined budget and planning, and with respect of quality standards.

This position is based in Swiftwater, Pennsylvania and is a full-time role.

Your Role

Key accountabilities

Ensure optimal Trial Related Material (TRM) supply to sites, and optimize sample transportations planning through to partner oversight.

  • Capture TRM requirements from study protocol design and objectives with clinical team inputs.
  • Define with GCI and GTOM sample labelling pre-requisites and sample transportation planning to respect study testing milestones.
  • Develop the study TRM specifications, organizes pre-quotation meetings with the partner, and reviews the quotes with procurement support.
  • Define the TRM distribution specifications and strategy depending on participating countries and planned sites recruitment.
  • Review quotes balancing savings and quality.
  • Interfaces with the CPMO to release the Purchase Order.
  • Organize and leads the KOM with the partner to clarify the study objectives and planning, the expected deliverables according to the defined performance indicators and the defined budget.
  • Coordinate TRM Import License according to countries specificities.
  • Leads regular meetings with the partner Project Manager to adjust the plans according to study preparation progress and changes.
  • Is accountable for Logistics budget defined by the Global Logistics Manager, following payments in collaboration with CPMO till final reconciliation.

Ensure optimal vaccines shipment and destruction strategy

  • Analyze the site IMP Check lists filled in by the CRAs during SAV to capture site storage and destruction capabilities, and cold chain management information (equipment and temperature data loggers).
  • Attend CSC KOM and provide inputs to define the distribution and destruction strategy.
  • Contribute to IRT set-up if needed under the GTOM leadership and uploads randomization list from XGrid.
  • Contribute to PADIS.
  • Provide country greenlights.
  • Check consistency of vaccine needs with study current data (recruitment rates) and adjusts distribution.
  • Trigger shipment requests.
  • Manage destructions.
  • Is accountable of the vaccine reconciliation at country level (sites and depots).
  • Files relevant documentation in the eTMF according to the CIL and embargo mode rules if needed.

Present study information and logistics status

  • Participate in Investigator Meetings and CRA trainings.
  • Provide study logistics updates/progress to the clinical team and any reports requested by the GTOMs.
  • Promote efficient solutions to issues

Manage cold chain and provide Cold Chain Break determinations to sites with the support of SQO if needed

Prepare and answer Audits/PAI/ Inspections

  • Conduct regular TMF QCs.
  • Share audit/Inspections lessons learned with CLC team and takes into consideration important observations shared by the GTOMs.
  • Is accountable for up-to-date Logistics artifacts in EDMS.

Your Profile

You must have:

  • A minimum of 2 years of logistics experience
  • Undergraduate/Bachelor’s degree (BAC + 4), at a minimum
  • Clinical trial knowledge
  • Good interpersonal skills
  • Multitasking skills
  • Ability to work independently
  • Ability to work under pressure
  • PC Skills (Word, Excel, PowerPoint)
  • Previous experience with (clinical) supply chain
  • Strong command of the English language (writing, reading, speaking)– native or fluent.

Preferable experience/skills:

  • Experience working in the pharmaceutical sector, preferably within the supply chain, clinical operations or manufacturing operations.
  • A good understanding of key principles related to clinical and/or pharmaceutical development operations (drugs, vaccines or medical devices).
  • A good understanding of good clinical and/or good manufacturing practices.
  • MS Office software (Word, Excel, PowerPoint, Outlook).

Job Type: Full-time

Experience:

  • Supply Chain Management: 2 years (Preferred)