Sr. Clinical Trials Project Manager

Responsibilities

Directs and coordinates all aspects of clinical research trials and acts as a liaison to study leadership and sponsor(s); Ensures study activities are meeting deadlines and manages overall study timeline; Provides oversight and mentoring to junior members of the study team; Directs the development and execution of clinical trial activities for multi-center industry sponsored drug trials, including developing and revising study timelines; Engages with Finance for budget development and budget management; Serves as liaison to the Principal Investigator, study leadership, sites, vendors and sponsor; Helps coordinate work between entire study team; Leads internal study meetings and monitors progress toward meeting team goals and completing action items; Participates in planning external meetings, including development of agenda and meeting materials and may be required to present or report out on action items; Mentors, trains, and manages more junior staff as part of a study project team; Provides professional direction within clinical trials coordination team; Oversees study team interactions with study sites; Drafts and/or completes internal review of study documents, such as protocols, amendments, study plans, DSMB reports, grant submissions, and annual reports, for review and approval by study leadership; Drafts requests and reports to regulatory agencies, such as IND application, annual IND update to FDA, etc.; Reviews monitoring reports and works with study monitors to finalize reports; Manages monitoring schedule in coordination with the monitoring team; Presents at larger scale external meetings, as well as other professional meetings

Requirements

Bachelor's degree and 5 years of relevant experience required; Or equivalent combination of education and experience; Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials required; Strong communication skills, interpersonal skills, attention to detail, and organization skills required

Nice to have

Master's degree preferred; Previous personnel/study team management experience preferred; CCRP - Certified Clinical Research Professional upon hire preferred; Certified Project Management Professional (PMP)-PMI upon hire preferred