Clinical Trial Associate III

hace 5 días

Madrid, Madrid, España Premier Research A tiempo completo
Premier Research is looking for a Clinical Trial Associate III to join our Functional Services Provider (FSP) team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

  • We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

  • Your ideas influence the way we work, and your voice matters here.

  • As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

This CTA role will be working for our FSP business, and we require immediate availability to start.

The role is offered as a fixed term contract with an anticipated end date of late November 2026.

What you'll be doing:

  • Assisting with eTMF (electronic Trial Master File) filing and administration on all studies including more complex studies

  • Supporting the Clinical Research Associate (CRA) and site personnel with site level document collection.

  • Coordinating logistics and planning of meeting, events, and training

  • Primary lead to disseminate announcements and training materials related to clinical system updates and enhancements, as required Co-Leads and participates in project team meetings, prepares meeting minutes, and maintains action/decision logs

  • Creating, maintaining and providing quality checks for tracking tools and database repositories.

  • Performs Clinical Inspection Readiness and Quality Management System activities (e.g., deviations and CAPAs)

  • Tracking non-TMF documents and study status.

  • Reporting document collection and tracking issues.

  • Maintaining and leading CTA team in clinical inspection readiness and supporting regulatory inspections and/or audits as required.

What we're searching for:

  • 5 years clinical research "CTA-like" work and must include hands on experience of audit preparation

  • Exposure at working with within a smaller company environment is essential

  • Experience with CROs and vendors

  • TMF experienced with workflows, document statuses, structure, compliance review

  • Wingspan and Veeva experience will be considered as advantageous

  • Study finance support activities

  • Support metric reporting and compliance oversight meeting management including minutes, agenda, action items, etc.

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