Principal Clinical Scientist

ResponsibilitiesConduct site selection and qualification, negotiating budget and contracts.Develop clinical study plans and protocols, review clinical trial documentation, draft clinical study reports.Oversee clinical site training in collaboration with clinical research manager to ensure accurate execution of clinical protocols.Oversee the development of clinical study database by third party, review and summarize clinical data, perform data analysis and reports.Collaborate with Regulatory to prepare FDA pre-submission and submission packages.Overseeing clinical sites, central lab, and other third parties to ensure issues are resolved timely.Education and ExperienceMS or PhD in life sciences or related discipline.Minimum 10 years of clinical research experience for medical device and IVD products. Minimum 3 years' experience with rapid self-test IVD products is required, specialty in respiratory diseases or STD is preferred. Experience in communicating with the FDA is desirable.

Created: 2025-02-04