Part-time Clinical Trials Assistant

il y a 1 semaine


Bruxelles, Région de Bruxelles, Belgique Warman O'Brien Temps plein

Within this role, you will be required to provide operational support to Global Clinical Site Management (CSM) to deliver projects within planned timelines and according to the required standards of quality and compliance.


Responsibilities will include:

  • Obtain, QC and file essential documents in eTMF from internal and external stakeholders
  • Conduct eTMF reviews to identify needed corrections / gaps and obtain missing documents
  • Prepare inventory lists of study files in eTMF system
  • Complete group and trial level trackers and checklists
  • Support vendor access management
  • Perform site (re)supply management and site to site transfer of supplies.
  • Print documents and ship to sites upon request
  • Prepare Investigator Site File
  • Support maintenance of the CTMS system
  • Support CDA activities
  • Review the site invoices
  • Perform checks on Site Regulatory Packages (SRP), Form FDA1572s and PI CVs as necessary.
  • Customize country specific ICF and other site specific documents with site details
  • Support the implementation of new technologies/systems in clinical trials managed by the CSM team.

Requirements of the role:

  • 2+ years as a CTA
  • Ability to be creative and flexible and function in a fastpaced environment
  • Able to liaise and discuss with internal and external stakeholders
  • Ability to learn and master new technologies and systems
  • Good verbal and written English
  • Excellent communication skills and attention to detail
  • Highly proficient in MS Office Suite
  • Ability to learn new tasks and skills
  • Strong organizational and time management skills
  • Positive attitude towards Change Management

What you get in return:

  • A longterm contract with a global pharma
  • A competitive hourly rate

Job Type:
Part-time

Part-time hours: 20 per week

Schedule:

  • Monday to Friday

Ability to commute/relocate:

  • Bruxelles: Reliably commute or planning to relocate before starting work (required)

Work Location:
In person
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