Manager, Clinical Trials Proj

Rochester, NY

GENERAL PURPOSE:

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 in addition to manages senior members of the team in a supervisory capacity.

RESPONSIBILITIES:

  • Independently 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. May be asked to manage more complex protocols and/or larger scale industry sponsored trials.

  • 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 trials coordination team. Monitors progress toward meeting team goals and completing action items.

  • Serves as liaison to the Principal Investigator, study leadership, vendors and sponsor. Oversees entire study team, internal and external, including clinical trial sites (average 20 per trial), clinical and research laboratories, study medical monitors, biostatistics core, and data management team. Represents study team in meetings.

  • 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., 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.

QUALIFICATIONS:

  • Bachelor’s degree required

  • Master’s degree preferred

  • 6 years of relevant experience or equivalent combination of education and experience required

  • Previous leadership experience required

  • 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

  • CCRP – Certified Clinical Research Professional upon hire preferred

  • Certified Project Management Professional (PMP)-PMI upon hired preferred

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $77,216 - $115,824 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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