About this role
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. The Senior Manager, Global Clinical Science function provides scientific expertise necessary to design and deliver clinical studies and programs. Position Summary / Objective Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct May serve as Clinical Trial Lead for one or more trials May lead or support trial level activities for one or more trials with the necessary supervision May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members Position Responsibilities Collaborate and liaise with external partners (e.g., KOLs) Seek out and enact best practices with instruction Provide regular and timely updates to manager/management as requested Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required Conduct literature review Submit clinical documents to TMF Develop site and CRA training materials and present these at SIVs and Investigator meetings Review clinical narratives Monitor clinical data for specific trends Develop Data Review Plan in collaboration with Data Management Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)