Oversee subject recruitment and enrollment goals, determining effective strategies for recruiting participants and retaining them in long-term clinical trials, and oversee data management by developing and managing systems to organize, collect, report, and monitor data, and by extracting, analyzing, and interpreting study data. Ensure regulatory compliance by auditing operations, including laboratory procedures, leading corrective actions, monitoring Institutional Review Board submissions and renewals, regularly inspecting study documents, and working with the principal investigator to submit Investigational New Drug applications to the FDA when applicable.