Start up Specialist Denmark

Resourcing Life Science

Denmark

On-site

DKK 373,134 - 522,388

Full time

14 days+

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Job summary

Resourcing Life Science is looking for a Start up Specialist based in Denmark. The role involves overseeing CA and Ethics Committee submissions and ensuring compliance with GCP guidelines. Candidates should have at least a Bachelor's in life-science and 2 years of experience in a CRO or Pharma environment.

Fluency in Swedish and Norwegian is required, along with strong communication skills. This position offers a full-time role within a global CRO dedicated to supporting the biotech and pharmaceutical industries.

Qualifications

  • Minimum 2 years in EC & CA submissions within a CRO, Pharma, Biotech in Denmark.
  • Experience in clinical studies phase II-III.

Responsibilities

  • 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.

Skills

Excellent communication skills
Fluent Swedish
Fluent Norwegian

Education

Bachelor degree in life-science

Job description

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 office based in Denmark.

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 2 years in EC & CA submissions within a CRO, Pharma, Biotech in Denmark
  • Experience in clinical studies phase II-III
  • Excellent communication skills
  • Fluent Swedish & Norwegian
  • FTE: 1.0
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