Location: Remote-based (EST general hours of operation)
Duration: 6 months (likely extension)
Hours per week: 40
Start Date: ASAP
Our client is currently in need of a Sr Clinical Study Manager for a progressing Phase I Oncology Study. The study is a global-based project and candidates considered will require working knowledge of trials relating to EU studies. As the trial evolves from Phase I to Phase II activities, they are adding additional sites (there are 60 sites total) and the selected resource would be assisting with data reviews/analysis, regulatory submissions documentation review, sponsor oversight, ICF’s, site badges, regulatory package reviews, sample processing, imaging, troubleshooting and other related activities.
This project would be within a start-up environment where there are a lot of moving parts where constant & effective communication will be needed as well as having overcast to potential issues that could arise & knowing how activities overlap or affect one another (for example, if ICF isn’t reviewed on time, this person should know the potential setbacks or butterfly effects of repercussions). Critical thinking, clear communication, cross-functional collaboration, and someone who is professionally polished will be required for this project. 8+ years with relevant job description experience is required as well as global trial (EU) expertise and early phase trials (Phase I-II). Experience within oncology, lung cancer, or rare disease studies is preferred. Medidata Rave is also preferred but not required.
Sr Clinical Study Manager (233665) Remote