Start up Specialist Poland

Resourcing Life Science Ltd.

Polska

On-site

PLN 60,000 - 90,000

Full time

14 days+

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Job summary

Resourcing Life Science Ltd. in Poland is seeking a Start up Specialist for a Global CRO to support CA & EC submissions across studies and ensure regulatory readiness.

You will prepare site contracts, translate documents for submissions and maintain up-to-date knowledge of GCP/ICH guidelines while supervising study conduct in compliance with applicable laws. Fluent English and Polish, a life-science degree, and 1 year in EC/CA submissions are required.

Qualifications

Bachelor degree in life-science required.
Min 1 year EC & CA submissions experience in Poland CRO/Pharma.
Clinical studies phase II-III experience.
Fluent in English and Polish.
Excellent communication skills.

Responsibilities

Responsible for CA & Ethics Committee submission.
Prepare & negotiate site contracts for assigned studies.
Keep up to date with GCP and ICH guidelines for clinical research.
Translate and coordinate translations for submission documents.
Supervise study conduct according to GCP and applicable laws.

Skills

Excellent communication skills

Fluent English

Fluent Polish

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 in Poland.

Job Overview

Responsible for CA & Ethics Committee (EC) submission
Prepare & negotiate site contracts for the assigned studies
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