Manager – Clinical Trials Project

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:

400980 Neuro-Ctr Health & Tech/Admin

Work Shift:

UR - Day (United States of America)

Range:

UR URG 113

Compensation Range:

$77,600.00 - $116,400.00

Responsibilities:

Leads and oversees academic research activities focused on patient reported outcome measure development and validation. Manages a team of research staff responsible for data collection, documentation, and regulatory compliance— ensuring studies meet quality standards, regulatory guidelines, and critical timelines and milestones. Provides training, mentorship, and workflow oversight to research personnel to ensure consistency and accuracy in study execution. Works collaboratively with investigators, sponsors, and project stakeholders to advance the scientific and operational goals of the CHeT Outcomes division.

ESSENTIAL FUNCTIONS

• Oversees day-to-day operations of national and international research studies. Manages project teams, ensuring data integrity, protocol adherence, and timely completion of project deliverables. At direction of CHeT Outcomes Assistant Director and Director, monitors workflow across studies to ensure adequate coverage, quality, and efficiency.
• Trains, mentors, and evaluates research staff to ensure proper understanding and consistent application of research protocols, data management procedures, and ethical research standards. Develops and maintains study training materials, to provide consistency and excellent in all research studies. 
• Collaborates with principal investigators and project leadership to design, develop, and implement study protocols, data collection tools, and quality assurance processes. Coordinates with external collaborators and crossfunctional teams across CHeT and UR to resolve study issues.
• Reviews study data, progress reports, and documentation to ensure accuracy, completeness, and compliance with institutional, sponsor, and regulatory requirements. Tracks study timelines, deliverables, and budgets.
• Develops, documents, and implements Standard Operating Procedures (SOPs) for the CHeT Outcomes Group.
• Manages systems and processes for data entry, documentation, and reporting. Supports preparation of study-related publications, abstracts, and presentations..
• Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines. Manages and evaluates resulting study changes. Demonstrates accountability for continuous learning in accordance with GCPs. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor’s degree in relevant field required
• Master’s degree in relevant research or science field preferred
• 6 years of relevant experience or equivalent combination of education and experience required
• Experience in human subject research or outcomes development research, including research coordination, data management, project oversight, and leadership preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Strong understanding of human subjects research regulations, data management, and scientific documentation required.
• Proven ability to lead, train, and mentor staff required.
• Excellent organization, communication, and problem-solving skills required. 
• Experience with data analysis and research software preferred

LICENSES AND CERTIFICATIONS

• SOCRA – Certification in Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) 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.