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Clinical Supply Support Specialist Services - Spain - FSP

Key Facts

Remote From: 
Full time
Mid-level (2-5 years)
English

Other Skills

  • Communication
  • Time Management
  • Organizational Skills
  • Detail Oriented
  • Problem Solving

Roles & Responsibilities

  • Bachelor's degree in a related field with internship or prior industry work experience
  • 2+ years of experience in Clinical Supplies
  • 2+ years of experience in QA/Regulatory
  • 2+ years of experience in Supply Chain, Manufacturing, Procurement, or equivalent biopharma experience

Requirements:

  • Oversee Clinical Supply planning and monitoring: inventory planning, execution, risk assessment, stocking levels and trends; pull data for metrics reporting and ensure timely procurement of comparator drugs and ancillary supplies; track and update comparator documentation
  • Coordinate shipments and depot logistics: initiate non-system shipments, monitor delivery schedules, coordinate depot transfers and site return shipments; manage temperature excursions
  • Manage eTMF and documentation: create/update EDL, update comparator IMN, maintain eTMF document management per regulatory requirements, QA/QC releases, and TMF uploads into VEEVA; assist in UAT testing
  • Administer Clinical Supply systems and support: manage CSS email inbox, provide IRT system access for study users, complete quarterly EDL/IRR/StiL reviews, manage data entry in ASIST/spreadsheets/Teams and assist in UAT testing

Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel are currently recruiting for an Clinical Supply Support Specialist Services to join one of our growing sponsors in Spain.

Key Responsibilities:

Clinical Supply & Inventory Planning & Execution

  • Supply monitoring, assessment and oversight activities (risks, stocking levels, trends)

  • Pull relevant data for metrics reporting & maintain metrics

  • Process requisitions and ensure timely procurement of comparator drugs & ancillary supplies

  • Track and manage comparator documentation updates

Clinical Supply Shipments

  • Initiate non-system generated shipments

  • Monitor and track comparator drug delivery schedules

  • Coordinate Depot transfers & site return shipments

  • Temperature excursion management and resolution

Clinical Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)

  • Expected Document List (EDL) creation

  • Update comparator IMN (Item Master Number)

  • Update and maintain eTMF Document Management per regulatory requirements

  • Request QA/QP Releases

  • Pack-and-label kit and sequence reconciliation

  • Inspection Readiness activities

  • IRT management activities, including IRT Alert management and UAT activities

 IP / Ancillary Supplies Compatibility Review

  • Receive and triage request, forward to FDG for review

  • Perform internet searches and contact manufacturers for information

  • Data entry of information into database (ASIST or spreadsheet) and Teams

 Clinical Supply Systems

  • Manage CSS Email Inbox

  • Manage IRT system access for users for all studies

  • Complete EDL, IRR and StiL reviews every 3 months for all studies

  • Manage all TMF documentation uploads into VEEVA

  • Assist in UAT testing

Minimum Years of Experience:

Minimum education requirements:

Bachelor’s degree in a related field with an internship or prior industry work experience.

2+ years of experience in the following fields:

  • Clinical Supplies

  • QA/Regulatory

  • Precision Medicine

  • Supply Chain

  • Manufacturing

  • Procurement

  • Or equivalent research/commercial biopharma experience

If you are interested, please apply or send your CV to marta.kuniewicz@parexel.com

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