Location: Newark DE
Duration: 6 Months+
Under supervision of Clinical Affairs Sr. Manager or Project Manager, works with relevant departments (R&D, Regulatory Affairs, Medical Affairs, Validations, Product Support, Marketing) to aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms.
Remains current with regulatory requirements for in vitro diagnostic products.
With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including collection, timely review and analysis of data generated.
Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data.
Knowledge of GCP and Human Subject Protection for the conduct of clinical trials
Knowledge of regulatory requirements for in vitro diagnostic products
Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications
Good knowledge of the in vitro diagnostics industry
Good technical background to understand and communicate current and new technologies
Laboratory experience is desirable
Ability to work on multiple projects simultaneously.
Must be able to work within constraints of time and budget
25% travel required
EDUCATION and/or EXPERIENCE
B.A./B.S. or equivalent; three to five years related experience and/or training; or equivalent combination of education and experience.