- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND .Lead the CRO and vendor selection process in collaboration with the study team… more
- University of Colorado (Aurora, CO)
- …Professional (CCRP or equivalent). + Experience submitting Investigational New Drug ( IND ) applications. + Certified Associate in Project Management (CAPM), ... Clinical Trials Operations Manager - 33671 University Staff **Description** **University...the experience on a year-for-year basis. + At least 4 years of professional level experience in clinical trial… more
- University of Colorado (Aurora, CO)
- …including but not limited to study workloads and characteristics (multicenter, IND /IDE, etc), opening timelines, and accruals. + Develop internal relationships with ... strategic goals with guidance from the OCRST Program Director and Deputy Associate Director of Clinical Research. + Collaborates with the Data Safety Monitoring… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …integrity and respect in all we do, create and deliver. The Associate Director/Director Clinical Development, will be responsible for the leadership, oversight, and ... studies. Develop and maintain relationships with sites and Investigators. 4 . Provide medical monitoring, which includes reviewing study participant eligibility,… more
