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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.

Job Location (Full Address):

265 Crittenden Blvd, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400981 Neuro-Ctr Health & Tech/CTCC

Work Shift:

UR - Day (United States of America)

Range:

UR URG 112

Compensation Range:

$70,197.00 - $105,295.00

_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._

Responsibilities:

GENERAL PURPOSE

The Sr Clinical Trials Project Manager directs and coordinates all aspects of multi-center international 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 managing overall study timeline. Provides oversight and mentoring to more junior Clinical Project Coordinators on the study team.

ESSENTIAL FUNCTIONS

+ 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.

+ Oversees entire study team, 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 and during training sessions with sites.

+ Leads internal study meetings and monitors progress toward meeting team goals and completing action items.

+ Participates in planning larger scale external meetings, including development of agenda and meeting materials.

+ Mentors, trains and manages more junior Clinical Project Coordinators 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 (e.g., protocols, amendments, study plans, DSMB reports, grant submissions, annual reports) for review and approval by study leadership.

+ Drafts requests and reports to regulatory agencies (e.g., 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, and well as other professional meetings.

Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

+ Bachelor’s degree. Required

+ Master’s degree.

+ 5 years of experience with clinical trials. Required

+ Or equivalent combination of education and experience. Required

+ Previous personnel/study team management experience. Preferred

KNOWLEDGE, SKILLS AND ABILITIES

+ Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials. Required

+ Required Strong communication skills, interpersonal skills, attention to detail and organization. Required

LICENSES AND CERTIFICATIONS

+ CCRP - Certified Clinical Research Professional upon hire preferred

+ Certified Project Management Professional (PMP)-PMI upon hire preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.

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Learn. Discover. Heal. Create.

Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.

If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals

At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.