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Clinical Affairs Manager

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Clinical Affairs Manager

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.

The client is amongst the rising stars in the medical devices market with their breakthrough technology.

ROLE DESCRIPTION

You are the guide and monitor of three clinical studies on several continents. You start out as the manager of a small pilot study and will be part of the US trial and help set up another trial in the EU. You will attend OR surgeries as well and report results to the senior clinical affairs manager.
There will be monthly travel involved to the facility in Switzerland and occasional further travel depending on the study sites.

RESPONSIBILITIES

You start out as the responsible person for the pilot study. You will gradually take over the study in the US depending on your current experience level. You will help set up the pivotal study in the EU and help identify and select study sites.
You review clinical data and manage documentation and reports. There will be collaboration with the company's R&D team, QA and clinical affairs team. You are responsible for reporting data and trial statuses to senior management.

REQUIREMENTS

- Over 5 years of clinical trial experience in Class III medical devices
- Familiar with EU and FDA regulations
- Proven experience in first man studies
- Experience/capability to join surgeon team to keep an eye on results; medical education is not required as the CMO takes care of that
- Fluent in English, German is a plus
- Availability to travel

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Naut van Osnabrugge.

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SIRE Life Sciences®

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