Sr. Clinical Study Lead
Leading In-Vitro Diagnostics company
Key role in the project core team
Leading In-Vitro Diagnostics company. Global presence with 35 subsidiaries in over 25 countries and a distribution partner network in more than 60 countries.
- 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.
- Bachelor's degree in, life sciences, biomedical or medical related areas
- Minimum 5 years working experience of clinical study within vitro diagnostic devices
- Working experience in Clinical Affairs/Operations and experience with diagnostic clinical
Development of a growing business unit directly under APAC. Career opportunities on a truly global scale.