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.
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.
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.
- 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
- Supply Chain Management: 2 years (Preferred)