Country Approval Specialist Germany

£50000 - £51000 per annum
  1. Permanent
  2. Clinical Scientist
  3. Germany
Munich, Germany
Posting date: 01 Apr 2021

An opportunity has arisen for a Country Approval Specialist, in Germany. This is an exciting opportunity to join a startup delivering the set up for Clinical trials, collaborating to improve processes, cycle and flexibility.

Job Responsibilities

  • Prepare, review and coordinate, under guidance, local regulatory submissions in alignment with global submission strategy
  • Provide, under guidance local regulatory strategy advice to internal clients
  • Provide project specific local SIA services and coordination of these projects
  • May have contact with investigators for submission related activities
  • Key-contact at country level for either Ethical or Regulatory submission-related activities
  • May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
  • May develop country specific Patient Information Sheet/Informed Consent form documents
  • May assist with grant budgets(s) and payment schedules negotiations with sites.
  • Support the coordination of feasibility activities, as required, in accordance with agreed timelines
  • Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
  • Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
  • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Skills and Requirements

  • Bachelor's degree
  • 0 - 2 years related experience or equivalent combination of education, training, & experience
  • Effective oral and written communication skills
  • Excellent interpersonal skills
  • Strong attention to detail and quality of documentation
  • Excellent English and German language and grammar skills at least to C1 level
  • Basic medical/therapeutic area and medical terminology knowledge
  • Ability to work in a team environment or independently, under direction, as required
  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation

To Apply

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