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Clinical Trial Application Specialist
☞ PharmiWeb.jobs: Global Life Science Jobs
View: 83
Update day: 03-04-2024
Category: R & D IT - Software
Industry: Staffing Recruiting
Position: Entry level
Job type: Contract
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Job content
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.
- 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.
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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Deadline: 18-05-2024
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