Logistics Associate at PE Global

London, London - England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

16 Dec, 26

Salary

40000.0

Posted On

17 Sep, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Transportation & Logistics

Description

Job ResponsibilitiesWorks with the clinical logistics digital systems manager and change manager to ensure enrollment readiness
Works with the CRO to acquire trial site information to pass to digital systems for configuration
Participates in trial Site Initiation Visit (SIV) training
Executes dry runs for trial sites that require it
Travel as needed for in-person dry runs
Facilitates trial participant registration in the Salesforce cell journey orchestration platform
Ensures the trial participant meets clinical trial eligibility criteria prior to arranging apheresis collection
Ensures supply is at the trial site to facilitate apheresis collection
Works with 3PLs to arrange transport of apheresis material to Kite manufacturing
Uses the cell journey orchestration platform, 3PL systems, and communication with trial site to ensure product traceability and unbroken chain of identity (CoI) and chain of custody (CoC).
Tracks customs clearance and confirms delivery of apheresis product at manufacturing
Tracks manufacturing status and relays status and potential delays to the clinical trial site
Works with manufacturing Site Planning and QA Product disposition to arrange timely transport of QA released final IP back to the clinical trial site
Communicates expected delivery date to the clinical trial site and Study Management Team (SMT)
Tracks product pick-up, transit, and delivery of the final IP to the clinical trial site using the Salesforce cell journey orchestration platform, 3PL systems, and direct communication with the trial site and 3PL.
Uses the ERP to submit and book cell order for manufacture
Verifies cell order bookings to ensure accuracy and completeness in concert with other logistics staff
Tracks and orders apheresis shipper kits for clinical trial sites to ensure clinical trial enrollment readiness
Ensures on-site (trial site) apheresis shipper kits are not expired using tools provided by clinical logistics management as well as by direct confirmation with trial site CRCs
Works with manufacturing Site Planning to order liquid nitrogen (LN2) dewars to enable shipment of final IP
Ensures LN2 dewars are ordered early enough to ensure smooth operations and ensures dewars are returned immediately after use
Participates in clinical trial Study Management Team meetings
Works with various functions at manufacturing to ensure smooth operations
Uses clinical logistics systems to generate customs invoices to ensure smooth cross-border transport of apheresis and final product IP
Works closely with GTC to provide visibility to all incoming and outbound cross-border shipments
Works with manufacturing QA and RA as needed to facilitate country specific health authority shipment requirements
Communicates with QP in countries that require in-country release to ensure timely delivery of final product
Escalates execution risks and process gaps to management for awareness
Ensures logistics documentation is inspection ready and filed in accordance with applicable SOPs and eTMF requirements
Maintains complete and accurate CoI and CoC documentation for all shipments
Anticipates logistics risks and works with 3PLs and clinical logistics management to mitigate
Monitor active shipments, identify risks or deviations, and proactively triage and resolve logistics issues impacting patient treatment timelines.
Serve as the day-to-day logistics point of contact for clinical trial sites, CROs, manufacturing sites, and internal stakeholders.
Participate in the Clinical Logistics 24/7 on call rotation to support time critical logistics events outside standard business hours

RequirementsBachelor’s degree in Life Sciences, Supply Chain, Business, Information Technology or related field preferred
Experience
Experience in clinical logistics, clinical operations, or clinical supply chain within the biopharmaceutical industry.
3+ years with a high school diploma
0+ years with a bachelor’s degree
Basic understanding of end-to-end clinical trial operations, including patient-specific logistics, global trial execution, and their impact on systems and operations.
Any experience with cold-chain logistics or temperature-controlled biologics
Any experience with ERP systems (EBS, SAP, etc.)
Any experience with clinical trial tools and systems (CTMS, EDC, eTMF, IRT, IXRS, etc.)
Any experience with DCS and QMS systems (Veeva, Agile, etc.)
Basic knowledge of GCP, GMP, GxP, ICH, IATA principles and regulatory requirements.
Skills
Excellent communication, and collaborative skills.
Strong problem-solving abilities.
Ability to manage complexity and multiple priorities in a fast-paced environment.
Proficiency with Microsoft Office, SharePoint, Smartsheet, and other business systems

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Responsibilities

Job ResponsibilitiesWorks with the clinical logistics digital systems manager and change manager to ensure enrollment readiness
Works with the CRO to acquire trial site information to pass to digital systems for configuration
Participates in trial Site Initiation Visit (SIV) training
Executes dry runs for trial sites that require it
Travel as needed for in-person dry runs
Facilitates trial participant registration in the Salesforce cell journey orchestration platform
Ensures the trial participant meets clinical trial eligibility criteria prior to arranging apheresis collection
Ensures supply is at the trial site to facilitate apheresis collection
Works with 3PLs to arrange transport of apheresis material to Kite manufacturing
Uses the cell journey orchestration platform, 3PL systems, and communication with trial site to ensure product traceability and unbroken chain of identity (CoI) and chain of custody (CoC).
Tracks customs clearance and confirms delivery of apheresis product at manufacturing
Tracks manufacturing status and relays status and potential delays to the clinical trial site
Works with manufacturing Site Planning and QA Product disposition to arrange timely transport of QA released final IP back to the clinical trial site
Communicates expected delivery date to the clinical trial site and Study Management Team (SMT)
Tracks product pick-up, transit, and delivery of the final IP to the clinical trial site using the Salesforce cell journey orchestration platform, 3PL systems, and direct communication with the trial site and 3PL.
Uses the ERP to submit and book cell order for manufacture
Verifies cell order bookings to ensure accuracy and completeness in concert with other logistics staff
Tracks and orders apheresis shipper kits for clinical trial sites to ensure clinical trial enrollment readiness
Ensures on-site (trial site) apheresis shipper kits are not expired using tools provided by clinical logistics management as well as by direct confirmation with trial site CRCs
Works with manufacturing Site Planning to order liquid nitrogen (LN2) dewars to enable shipment of final IP
Ensures LN2 dewars are ordered early enough to ensure smooth operations and ensures dewars are returned immediately after use
Participates in clinical trial Study Management Team meetings
Works with various functions at manufacturing to ensure smooth operations
Uses clinical logistics systems to generate customs invoices to ensure smooth cross-border transport of apheresis and final product IP
Works closely with GTC to provide visibility to all incoming and outbound cross-border shipments
Works with manufacturing QA and RA as needed to facilitate country specific health authority shipment requirements
Communicates with QP in countries that require in-country release to ensure timely delivery of final product
Escalates execution risks and process gaps to management for awareness
Ensures logistics documentation is inspection ready and filed in accordance with applicable SOPs and eTMF requirements
Maintains complete and accurate CoI and CoC documentation for all shipments
Anticipates logistics risks and works with 3PLs and clinical logistics management to mitigate
Monitor active shipments, identify risks or deviations, and proactively triage and resolve logistics issues impacting patient treatment timelines.
Serve as the day-to-day logistics point of contact for clinical trial sites, CROs, manufacturing sites, and internal stakeholders.
Participate in the Clinical Logistics 24/7 on call rotation to support time critical logistics events outside standard business hours

RequirementsBachelor’s degree in Life Sciences, Supply Chain, Business, Information Technology or related field preferred
Experience
Experience in clinical logistics, clinical operations, or clinical supply chain within the biopharmaceutical industry.
3+ years with a high school diploma
0+ years with a bachelor’s degree
Basic understanding of end-to-end clinical trial operations, including patient-specific logistics, global trial execution, and their impact on systems and operations.
Any experience with cold-chain logistics or temperature-controlled biologics
Any experience with ERP systems (EBS, SAP, etc.)
Any experience with clinical trial tools and systems (CTMS, EDC, eTMF, IRT, IXRS, etc.)
Any experience with DCS and QMS systems (Veeva, Agile, etc.)
Basic knowledge of GCP, GMP, GxP, ICH, IATA principles and regulatory requirements.
Skills
Excellent communication, and collaborative skills.
Strong problem-solving abilities.
Ability to manage complexity and multiple priorities in a fast-paced environment.
Proficiency with Microsoft Office, SharePoint, Smartsheet, and other business systems