Clinical Startup & Submissions Specialist

Resourcing Life Science; Denmark; On-site; DKK 373,134 - 522,388; Full time

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

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.