Clinical Supply Support Specialist Services - Spain - FSP

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 [email protected]