Clinical Study Manager/manager, Clinical Research
Manages Clinical Operations, including 3 direct reports. Oversees clinical trials from development to closeout, with a focus on surgical and wound care applications of a Section 361 tissue product. Responsible for providing guidance to all sites on study administration. Maintains regulatory filing and reporting. Creates and manages all study documents (protocol, ICF, contracts) and data tools including CRFs and study database. Manager of clinical trials for industry-sponsored trials reporting directly to Chief Medical Officer.
- Promoted to department manager in 2015.
- Organizes and oversees internal Clinical Events Committee
- Grew clinical department from running 3 studies at 3 sites to 10 studies at 50+ sites in 2 years, wrote and managed all clinical documents for these studies
- Builds departmental infrastructure with the goal of FDA compliance, including writing SOPs