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Remote GCS Document Specialist

New Haven, CT 06510

Posted: 05/15/2024 Employment Type: Contract Job Category: Procurement/Supply Chain Job Number: 606019 Is job remote?: Yes Country: United States

Job Description

GCS Document Specialist
Day-to-day Operations
  1. Collaborate with CSMs on maintenance of 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
  2. 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
  3. Assist CSMs in managing document review and approval in DocuSign/ Adobe e-Sign
  4. 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
  5. Streamline process for document storage and archiving across GCS studies by identifying and driving areas of improvement


Inspection Readiness Support
  1. Support CSMs during audit and inspection activities by compiling and requesting study documents in anticipation of auditor/inspectors’ requests
    1. Typically documents not already in BOX study folders
  2. Collaborate with TMF specialist to ensure all TMF filings are accurate and contemporized for all GCS studies, particularly ahead of study audits and inspections
  3. Assist CSMs with Storyboard creation and maintenance via communicating with involved functions and reviewing related study documents and/or TrackWise reports

Potential Areas of Support
  1. Act as the GCS POC for document storage transition from one BOX to Sponsor BOX and OneDrive
  2. Create and maintain GCS documents in Vault, the GMP environment
  3. 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 16.1.6 (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
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About New Haven, CT

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