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Specialist Clinical Data

Il y a 3 mois


Beerse, Flandre, Belgique Pauwels Consulting Temps plein
Outsourcing Coordinator - Analytical Development Department: PDMS Global Clinical Release and Stability

General Mission

  • Act as a Single Point of Contact (SPOC) for our external contract labs along with External Alliance Manager SPOC.
  • Ensure GMP compliance with regulatory requirements.
  • Support Analytical Development (AD) departments with their relationship and communication with external laboratories (ECLs) and Contract Development Manufacturing Organizations (CDMOs)
  • Support clinical release and stability (CRS) with capacity planning at preferred external contract labs.
  • Assist with the initiation of Work Orders (WOs)/Purchase Orders (POs) at external contract labs and CDMOs (through the close collaboration with External Alliance Manager, AD project managers, and Contract Management teams.
  • Assist with the scheduling of weekly/monthly analytical meetings with CDMOs and ECLs to support AD project timelines.
  • Support the Stability Project Owners, release planners and AD project managers with project timelines and due date tracking of analytical activities at CDMOs and ECLs
  • Connection with other ECL SPOC colleague and External Alliance manager to ensure adequate capacity planning at external ECL sites for AD activities.