Mgr, Clinical Trials Proj (L)

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Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400119 Surgery-Cancer Control

Work Shift:

UR - Day (United States of America)

Range:

UR URG 113

Compensation Range:

$77,216.00 - $115,824.00

Responsibilities:

The Manager, Clinical Trials Projects, leads and oversees the Project Management Team for the URCC NCORP Research Base, a $40M NIH-funded national clinical trial coordinating center overseeing a national network of 800+ community oncology practices. Reporting to the Executive Director of Research Operations, this role supervises the Project Management team and oversees project coordination across the Research Base clinical trial portfolio, including study startup, activation, amendments, timeline tracking, accrual/project status monitoring, and closeout for multisite Phase II and III cancer control and cancer care delivery clinical trials. The Manager works closely with Research Base leadership, Study Chairs, cross-functional operational teams, and external collaborators to ensure project management activities are timely, coordinated, compliant, and aligned with Research Base priorities. This role requires excellent people and conflict management skills, and an aptitude for motivating and inspiring colleagues. Creative and independent problem solving are necessary skills the Manager will need in order to be successful in this fast-paced, modern clinical research enterprise.

The Research Base is part of the Department of Surgery, Division of Supportive Care in Cancer, with our offices located in the Saunders Research building. This role is required to be in-office, with work hours/availability during standard business hours, within approximately 8:00am – 5:00pm. Occasional work outside of standard business hours may be required.

ESSENTIAL FUNCTIONS

Oversight of Project Management (PM) Team functions across all URCC clinical trials, and direct project management as needed.

• Coordinates study startup, protocol development support, activation, amendments, accrual/project milestone tracking, closeout, and publication/analysis transition points.
• Ensures PMs maintain accurate timelines, action logs, milestone trackers, and study-specific operational plans.
• Identifies barriers, timeline risks, resource constraints, and operational issues; works with Assistant Director to resolve or escalate as needed.
• Ensures PM work aligns with NCI expectations, Research Base priorities, and cross-functional team workflows.
• Is responsible for leading their own assigned clinical trials and performing associated PM when needed.
• Oversees and, when needed, directly performs PM cross-coverage.

Team Leadership and Performance Management

• Supervises team of Project Managers.
• Assigns, balances, and monitors PM workload across active studies and clinical trials in start-up.
• Provides onboarding, training, coaching, performance management, and corrective feedback.
• Supports hiring, retention, performance evaluations, promotions, and disciplinary processes for PMs.
• Ensures PMs understand study priorities, timelines, communication expectations, and handoffs for study reassignments and cross-coverage.

Cross-Functional Collaboration and Stakeholder Engagement

• Oversees the development and submission process and timelines across new clinical trials and amendments, assess competing priorities, and ensure that the timelines and actions required are clear.
• Serves as primary PM liaison to Assistant Director, Executive Director, Research Base leadership, Study Chairs, project teams, Regulatory, Data Management, IT, Finance, NCI-related contacts as appropriate, and URCC NCORP Research Base members.
• Attends regularly held meetings and presents relevant updates and reports to URCC leadership, Study Chairs, and others.
• Provides reports and is responsible for generating relevant data to support progress reports, grants, etc. as requested by URCC leadership.
• Coordinates PM inputs into protocol development, activation planning, amendments, recruitment/accrual monitoring, and study closeout.
• Ensures study teams and Research Base leadership receive operational updates and actionable project status information.
• Facilitates communication between PMs and cross-functional teams to resolve operational barriers.

Process Improvement, Compliance, and Operational Reporting

• Maintains and improves PM-related SOPs, templates, trackers, and project management workflows.
• Supports audit readiness and compliance with GCP, NCI, institutional, and Research Base expectations.
• Develops tools/reports for tracking study milestones, PM workload, project status, and operational risks.
• Recommends process improvements to Assistant Director and supports implementation across the PM team.
• Maintains knowledge of clinical trials operations, project management practices, GCP, NIH/NCI expectations, and institutional policies.

Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

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

KNOWLEDGE, SKILLS AND ABILITIES

• 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.

LICENSES AND CERTIFICATIONS

• CITI Human Subject Protections and Good Clinical Practice Certifications required upon employment.
• CCRP - Certified Clinical Research Professional upon hire preferred
• Certified Project Management Professional (PMP)-PMI upon hire preferred

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