Clinical Trial Associate

Details

  • Category: Central laboratories
  • Location: Lausanne
  • Starting date: Dec 02, 2019
  • Domain of experience: clinical trials
  • Level required: Mid-senior level
  • Years of experience: 2+

Your Role

In this role you will assist in set up and follow-up of the studies, management of appropriate documentation and actively supports the Clinical Research Associates and Clinical Trial Managers by creating, updating and distributing study tools, materials and documents. You will actively contribute to the project team and study goals.

Your Tasks

  • Support all activities and steps of the clinical study deliverables, as well as delivery of the clinical study according to the ICH GCP and other applicable regulations
  • Timely file and archive all study documents on eTMF under the responsibility of the Clinical Trial Manager and ensure inspection readiness of the Trial Management File
  • Coordinate issues resolution with CROs (i.e. timelines, tools, vendor’s issues…)
  • Manage vendors under supervision of the Clinical Trial Manager (attend or lead all dedicated meetings, review and approve meeting minutes, act as key point of contact for vendors, follow-up on budget and timelines, make purchase orders)
  • Follow up and dispatch invoices according to the relevant purchase orders, track payments to vendors and study sites, keep up to date information on financial agreements and payments
  • Create and distribute study team agenda and meeting minutes in a timely manner and support Clinical Trial Manager in meeting preparation
  • Assist the CTM in communicating the study progression (create newsletters, updates on patient recruitment, progress reports, milestones and overall timelines) with both internal and external stakeholders
  • Act as Backup and primary point of contact of the study in case of Clinical Trial Manager absence by directing the action items to the most appropriate person

Your Profile

  • Master or PhD degree in Life Sciences, Pharmacy, Biomedical Engineering or other relevant field
  • Strong knowledge of validated eTMF system, processes and related standards
  • Experience in management and filing of Trial Master File content and appropriate quality control
  • DIA Reference Model v3.0, Health Authority Inspection and Veeva Vault eTMF experience is a strong asset;
  • Minimum 2 years of experience as Clinical Trial Associate or similar experience in Pharmaceutical/Biotechnology Company or CRO with good knowledge of budget and invoicing requirements, drug development process and medical terminology;
  • Strong team player with customer focus and ability to work with others in a fast-paced matrix organization
  • Fluent English written and spoken

 

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