Coordinates investigator/site feasibility and identification process, monitors project timelines and patient enrollment, reviews monitoring visit reports, and manages clinical supplies management with vendors on a country and regional level.
Requirements
- Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
- Minimum of 4 years' site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
- Prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices.
- Strong experience in all types of monitoring visits in Phases I-III, and experience in Oncology, CAR-T Therapy, or other types of Cell Therapy, Gene Therapy, Radiation Therapy, or Radiopharmaceuticals, or Nuclear Medicine is preferred.
- Full working proficiency in English, proficiency in MS Office applications, ability to plan, multitask and work in a dynamic team environment, excellent Communication, collaboration, and problem-solving skills.