The Senior Clinical Trial Project Manager will independently manage multiple Phase I-Phase II Penn-Sponsored clinical research studies in order to ensure execution of clinical research and oversee clinical studies from concept to final close, including study start-up activities, study monitoring activities, data collection, project maintenance and project close-out activities.
Responsibilities Include: * Develops clear and measurable project management plans; Defines timelines, milestones, and limitations to project staff and study sites. * Monitor project status and timelines * Manage clinical projects/programs, including deliverables from all functional areas and vendors in accordance with contractual timelines and sponsor specifications. * Establishes project metrics and project schedules with client representatives. Provides at least monthly project updates. * Facilitate case report form development, review, approval, and finalization with the Data Management Team * Development of Manual of Procedures and site study binder including all required Sponsor Forms/Templates * Support clinical development of protocol/consent form documents * Facilitate local regulatory review committee approvals as required for multisite trials * Coordination of site initiation visit/site training * Review/process protocol exceptions/deviations * Prepare and process DSMB Reports; Organize and coordinate DSMB Meetings * Reporting of study progress and subject statuses; provide IND summary information for the IND annual report * Review/report the status of case report form completion and data query resolution * Develop and provide study and/or protocol amendment training to sites * Manage/maintain the Sponsor Trial Master Files for each project/site * Participate in SOP development.
The candidate must be a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables. This includes coordination with the clinical team, authoring manual of procedures for the conduct of the trial, attending and participating in trial-kick-off meetings (requiring limited travel to participating sites), and providing technical leadership and scheduling for the team to ensure deliverables. This candidate must also have a thorough knowledge of Federal Regulations and ICH-GCP guidelines, and a comprehensive understanding of clinical trial processes, and the conduct of clinical studies.
Internal Number: 43965
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.