Snr Clin Trials Admin
covance
Brussels, Belgium
20 uur geleden

Job Overview :

Covance is looking to recruit a CTA to join our sponsor in Belgium!!

Responsibilities :

TRIAL AND SITE ADMINISTRATION :

  • Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate / sign translation change request
  • DOCUMENT MANAGEMENT :

  • Prepare documents and correspondence
  • Collate, distribute / ship, and archive clinical documents o Assist with eTMF reconciliation
  • Updating manuals / documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders o Execute eTMF Quality Control Plan o Obtain translations of documents
  • REGULATORY & SITE START-UP RESPONSIBILITIES :

  • Provide to and collect from investigators forms / lists for site evaluation / validation, site start-up, and submissions
  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for IRB / ERC and support regulatory agencies submissions.
  • Publish study results for GCTO and RA were required per local legislation
  • BUDGETING, AGREEMENT, AND PAYMENTS :

  • Collaborate with finance / budgeting representatives for :
  • Develop country and site budgets (including Split site budget) Tracking, and reporting of negotiations
  • Maintenance of tracking tools
  • Contract development, negotiation, approval, and maintenance (e.g. CTRAs)
  • Update and maintain contract templates (in cooperation with the Legal Department)
  • Payment calculation and execution (investigators, vendors, grants)
  • Ensure compliance with financial procedures
  • Monitor and track adherence and disclosures,
  • Budget closeout.
  • Education / Qualifications :

    Bachelor of Science degree preferred or an equivalent scientific or commercial Higher Vocational Education with preferably experience in the healthcare field, pharmaceutical industry or clinical research.

    Experience : Experience :

    Experience :

  • Minimum 1-2 years in Clinical Research or relevant healthcare experience
  • Fluent English, French and Dutch
  • If you would like to learn more :

    Natalija.Vukadinovic covance.com

  • 31 (0) 61 293 9571
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