Opportunity to be a part of the leading in-vitro diagnostics partner trusted in the market to successfully lead the most innovative diagnostic technology through clinical and regulatory approvals. As an established diagnostics specialist, their expertise and reputation means they're entrusted to work with the most innovative and interesting IVD products in development.
- In the newly created Clinical Scientist role, you'll have the chance to dictate and strategize the clinical plans and protocols, working with start ups' amazing technologies as they navigate the clinical pathways all the way from conception to approval.
- Partner with start-up clients to understand their technology and clinical needs, prepare and present clinical study strategies and protocols for regulatory bodies accordingly
- Create Clinical and Analytical Study Protocols and support plans and procedures, including Informed Consent Forms (ICFs), Monitoring Plans and Data Collection Forms in conjunction with the assigned Project Team.
- Assist clients in identifying and contracting with potential Clinical Trial Sites and Reference Laboratories.
- Bachelor's degree in a health care or other scientific discipline or educational equivalent.
- 5-10 years’ experience in a clinical environment or medical devices industry, with specific experience within in vitro diagnostic devices.
- Understanding of U.S. Food and Drug Administration (FDA) laws and guidance.
Understanding of IRB guidelines and Common Rules
- Experience managing and taking responsibility for multiple projects at once from a consultative point-of-view.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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