Lab Manager

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.

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ESSENTIAL FUNCTIONS

• Directs the development and execution of clinical trial activities for multi-center industry sponsored 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 staff, including developing career plans and delivering performance appraisals.
• Leads internal and external meetings and provides professional direction within clinical trials 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, 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, such as 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.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 6 years of relevant experience required
• Master's degree preferred
• Or equivalent combination of education and experience
• Previous leadership experience required

KNOWLEDGE, SKILLS AND ABILITIES

• 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

LICENSES AND CERTIFICATIONS

• CCRP - Certified Clinical Research Professional upon hire preferred
• Certified Project Management Professional (PMP)-PMI upon hire preferred

EOE Minorities / Females / Protected Veterans / Disabled:

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.