Clinical Supply Chain Specialist - Massachusetts, United States - Absolute Staffing, LLC - Connecticut

Description

Global Clinical Supply Chain Specialist

Duration: 1 year June 2024 to July 2025

Job Type: Contract/"temp"

Remote: Candidate must be based in either Massachusetts, Connecticut, or New York

This is a 1-year contract assignment fully remote, but you need to be living/working in either Connecticut, Massachusetts or New York.

Summary

Contributes to the planning and ongoing delivery of investigational products by managing the supply chain, supporting the execution of studies and changes to the plans, including carrying out risk assessments and contingency planning where necessary, in support of Clinical Therapy Area and non-Clinical Therapy Area projects. This is a Clinical Supply support role position, working directly with the Clinical Supply Manager to complete documentations in support of varying clinical activities.

Day-to-day Operations

Collaborate with Clinical Supply Managers (CSMs)on maintenance of Global Clinical Supply (GCS) operations-related documents for all active and upcoming studies (list below)

Examples: checking for most current document versions, ensuring approval completeness, maintaining list of key study contacts, etc.

Ensure accuracy and completeness of GCS study documents in team storage space (BOX and SharePoint) by performing regular filing, review, and organization of controlled documents

Assist Clinical Supply Managers (CSMs) in managing document review and approval in DocuSign/ Adobe e-Sign

Interface with internal functions and external vendors(Almac, Catalent, PCI, Endpoint, etc.) to obtain and maintain GCS study documents generated in day-to-day GCS operations

Streamline process for document storage and archiving across GCS studies by identifying and driving areas of improvement

Inspection Readiness Support

Support Clinical Supply Managers (CSMs) during audit and inspection activities by compiling and requesting study documents in anticipation of auditor/inspectors' requests

Typically documents not already in BOX study folders

Collaborate with Trial Master File (TMF) specialist to ensure all TMF filings are accurate and contemporized for all Global Clinical Studies (GCS), particularly ahead of study audits and inspections

Assist Clinical Supply Managers (CSMs) with Storyboard creation and maintenance via communicating with involved functions and reviewing related study documents and/or TrackWise reports

Potential Areas of Support

Act as the Global Clinical Supply "Point of Contact" (GCSPOC) for document storage transition from one BOX to another company BOX and OneDrive

Create and maintain Global Clinical Supply (GCS) documents in Vault, the GMP environment

Assist with PO requests in terms of Smartsheet submission and quote approval in Coupa

Key GCS study documents: Packaging/Labeling/Distribution:

Request for Packaging (Blinded and Unblinded RFP), Variable Data Request, Label Links and Rand, Packaging Specifications (PS), Certificate of Compliance/Conformance (CoC),Certificate of Analysis (CoA), Certificate of Testing (CoT), Partial Manufacturing Certificate, QP certificates, IMP release Certificates, Global Distribution Specifications (GDS), Drug Return Instructions (DRI), Certificate of Destruction (CoD)

IRT:

IRT specifications (Endpoint PULSE and Almac IXRS),Endpoint DRIVE Specifications, User Acceptance Test (UAT) Log, IRT User guides, DRIVE User Manual, Drug Return Instructions (DRI), Data Change Requests (DCR), IRT Report for Returns Discrepancy, IRT Validation Certificate

Audit trail report requests for site/user changes for audits and inspections

Study Maintenance:

Study Protocol, Pharmacy Manual (PM), Vendor Oversight Plan (VOP- GCS and study-level), Meeting Minutes, Purchase Order (PO) requests, Clinical Supply Agreement (CSA)

Quality (with GCSQ and external QA):

Vendor Deviation Reports

CSR:

Appendix study lot information)

Vault (Tentative):

Clinical Label Approval Document (CLAD), Finished Product (FP) Specifications, Standard Operating Procedure (SOP) updates and lifecycle management

Italicized items are tentative

Disclaimer: This list is not comprehensive and is subject to change

Education:

Bachelor's degree required