Start up Specialist – Home Based – Belgium

Resourcing Life Science; Brussel Hoofdstad; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A global Clinical Research Organization is seeking a Start up Specialist to work remotely in Belgium. The ideal candidate should have a bachelor's degree in life-science and at least 1.5 years of experience in Ethics Committee and Competent Authority submissions within a CRO, Pharma, or Biotech. Responsibilities include managing submissions, keeping abreast of GCP and ICH guidelines, and overseeing study conduct. Fluency in English alongside Dutch or French is required.

Qualifications

• Minimum 1.5 years of experience in EC & CA submissions within a CRO, Pharma, or Biotech in Belgium.
• Experience in clinical studies phase II-III.

Responsabilités

• Responsible for CA & Ethics Committee (EC) submission.
• Keep up to date knowledge of GCP and ICH Guidelines for clinical research.
• Translation and co-ordination of translations for documents required for submissions.
• Supervising study conduct according to GCP requirements and all applicable laws.

Connaissances

Knowledge of GCP

Knowledge of ICH Guidelines

Excellent communication skills

Fluent in English

Fluent in Dutch or French

Formation

Bachelor degree in life-science

Description du poste

Company Description

Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Start up Specialist home based in Belgium.

Job Overview

• Responsible for CA & Ethics Committee (EC) submission
• Keep up to date knowledge of GCP and ICH Guidelines for clinical research.
• Translation and co-ordination of translations for documents required for submissions.
• Supervising study conduct according to GCP requirements and all applicable laws.

Key Requirements

• Bachelor degree in life-science
• Min 1.5 year in EC & CA submissions within a CRO, Pharma, Biotech in Belgium
• Experience in clinical studies phase II-III
• Fluent English & Dutch or French
• Excellent communication skills
• FTE: 1.0