Clinical Trial Application Specialist

☞ PharmiWeb.jobs: Global Life Science Jobs

Aussicht: 85

Update Tag: 03-04-2024

Ort: Bern Bern BE

Kategorie: R & D IT - Software

Industrie: Staffing Recruiting

Position: Entry level

Jobtyp: Contract

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Jobinhalt

Proclinical are recruiting for a Clinical Trial Application Specialist to join a pharmaceutical organisation. This role is on a contract basis and is located in Switzerland.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

Responsibilities

  • Partake in CTA actions for international clinical trials throughout the entire study lifecycle while under the supervision of the GRSL.
  • Both uphold and improve CTA procedures linked to CTA actions.
  • Partake in the development and improvement of both systems and solutions linked to CTA actions.
  • Serve as a Subject Matter Expert for all CTA-connected subjects.
  • Other duties may be assigned.

Key Skills And Requirements

  • Demonstrable experience in a relevant apprenticeship such as medicinal documentation, professional or equivalent.
  • Educated to an advanced degree level in a relevant field.
  • Familiarity in regulatory affairs or clinical research, ideally with experience in handling clinical trial authorisations.
  • Competent in using Veeva RIM and Veeva TMF.
  • Expertise on regulatory needs within key markets for obtaining clinical trial authorisation in particular EU/CTR.
  • Know-how of ICH regulations/GCP and present medical/scientific/regulatory know-how.
  • A customer focused individual when providing customer service.
  • Project management abilities, as well as planning and coordination abilities to meet deadlines.
  • Able to manage own time efficiently.
  • Communication skills both verbally and in writing.
  • Fluency in the English language.
  • Computer literacy.

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.

#Regulatory
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Frist: 18-05-2024

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