Manager, Clinical Trials Project, CHeT Outcomes

University of Rochester•City of Rochester, NY

20h•Onsite

About The Position

The Manager, Clinical Trials Project, CHeT Outcomes leads and oversees academic research activities focused on patient reported outcome measure development and validation. This role involves managing 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. The manager provides training, mentorship, and workflow oversight to research personnel to ensure consistency and accuracy in study execution. They work collaboratively with investigators, sponsors, and project stakeholders to advance the scientific and operational goals of the CHeT Outcomes division.

Requirements

Bachelor’s degree in relevant field required
6 years of relevant experience or equivalent combination of education and experience required
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.

Nice To Haves

Master’s degree in relevant research or science field preferred
Experience in human subject research or outcomes development research, including research coordination, data management, project oversight, and leadership preferred
Experience with data analysis and research software preferred
SOCRA – Certification in Clinical Research upon hire preferred
Association of Clinical Research Professionals (ACRP) upon hire preferred

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.
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.