Clinical operations Assistant

Company
Parexel
Location
Paris, France
Salary
Competitive
Posted
12 Apr 2019
Closes
12 May 2019
Ref
46964BR
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
  • Track , scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan.
  • Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP)
  • Photocopy, print distribute and retrieval of documents, as needed
  • Maintain basic quality check procedures to ensure accurate maintenance of documents
  • Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only)
  • Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance.


Qualifications

  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management
  • System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
  • Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines,
  • International and local regulations and applicable PAREXEL procedures
  • Ability to prioritize multiple tasks and achieve project timeline
  • Fluent in English and French

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