Clinical Trials Project Manager - Scheible lab

University of Rochester•City of Rochester, NY

10d

About The Position

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. The Clinical Trials Project Manager independently directs and coordinates all aspects of clinical research trials in a Contract Research Organization (CRO) environment and acts as a liaison to study leadership and sponsor(s). Individual ensures study activities are meeting deadlines and manages overall study timeline. Provides oversight and mentoring to more junior Clinical Project Coordinators on the study team in addition to managing Clinical Project Coordinators in a supervisory capacity.

Requirements

Bachelor's degree required with major course works in appropriate health, social science, or biological science field
6 years of relevant experience with clinical trials or equivalent combination of education and experience required.
Previous personnel management experience
Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials
Strong communication skills, interpersonal skills, attention to detail and organization required
Laboratory Safety (Biological/Chemical) Training

Nice To Haves

Master's degree preferred
Clinical research professional/project management certification upon hire preferred

Responsibilities

Independently directs the development and execution of clinical trial activities for multi-center NIH and industry sponsored clinical trials, including developing and revising study timelines.
Engages with Finance for budget development and budget management. May be asked to manage more complex protocols and/or larger scale industry sponsored trials.
Oversees study supplies purchasing and inventory, study sample inventory and transfer between study sites.
Liaises with data management team to ensure reliable and accurate specimen and clinical data collection.
Oversees and engages in study subject recruitment, sample collection, study subject compensation, communication with bedside team for study procedures
Mentors, trains and manages more junior Clinical Project Coordinators as part of a project team. In addition, manages other Clinical Project Coordinators in a managerial capacity, including developing career plans and delivering performance appraisals.
Leads internal and external meetings and provides professional direction within clinical research coordination team.
Monitors progress toward meeting team goals and completing action items.
Oversees entire study team, internal and external, including clinical research sites (average 3 per trial), clinical and research laboratories, study medical monitors, biostatistics core, and data management team.
Drafts and/or completes internal review of study protocol and final study documents for review and approval by study leadership.
Drafts requests and reports to regulatory agencies (e.g., MTA, DUA, IND application, annual IND update to FDA, etc.).
Plans large scale external meetings.
Presents at external study meetings as well as other professional meetings.
Other duties as assigned