- 求人を保存
- 求人を送信
- Leading In-Vitro Diagnostics company
- Key role in the project core team
企業情報
Leading In-Vitro Diagnostics company. Global presence with 35 subsidiaries in over 25 countries and a distribution partner network in more than 60 countries.
職務内容
- Accountable for the development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs.
- Accountable for study submission to IRB/IECs and for authoring Competent Authority submissions and may also submit to other Regulatory authorities.
- Accountable for managing and tracking of clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up internal and external communications for correction, trouble shooting, and prevention planning.
理想の人材
- Bachelor's degree in, life sciences, biomedical or medical related areas
- Minimum 5 years working experience of clinical study within vitro diagnostic devices
company
- Working experience in Clinical Affairs/Operations and experience with diagnostic clinical
studies
条件・待遇
Development of a growing business unit directly under APAC. Career opportunities on a truly global scale.
