EU CTA

Highly Competitive
  1. Contract
  2. Clinical Trial Assistant (CTA)
  3. United Kingdom
London, England
Posting date: 08 Jan 2024
58138

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Proclinical are recruiting for an EU CTA to join a biotech organisation. This role is on a contract basis and is located in London.

Responsibilities:

  • Accountable for evaluating and triaging requests for information from health authorities via CTIS for pertinent cross functional teams.
  • Help the EU regulatory lead to prepare proposal content plans and documentation for regulatory deliverables, for the management of clinical trials.
  • Support the definition, development and execution of procedures to meet the developing CTIS requirements.
  • You will raise, notify and solve any concerns that might influence proposal procedures or timelines in CTIS.
  • The ideal candidate will be allocated to one or more products under development to guarantee that clinical trial application approvals within the EU.
  • Serve as a technical expert in the EMA clinical trial.
  • Arrange for clinical trial submissions and notifications within a ground-breaking regulatory document management system and uphold tracking systems.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Experience with using CTIS (Clinical Trials Information System).
  • Familiarity with systems necessary to CTIS.
  • Knowledge of Viva Volt
  • Comprehension on EU clinical comprehension.
  • Past involvement in a reg team admin / administrative assistant / clinical reg admin or similar role.

If you are having difficulty in applying or if you have any questions, please contact Dracen Black at d.black@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#Clinical

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