Clinical Trials Project Manager

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

Opening: Worker Subtype: Regular

Time Type: Full time

Scheduled Weekly Hours: 40

Department: 400088 Pediatrics M&D Neonatology

Work Shift: UR - Day (United States of America)

Range: UR URG 113

Compensation Range: $77,216.00 - $115,824.00

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

The Clinical Trials Project Manager independently directs and coordinates all aspects of clinical research trials in a Contract Research Organization (CRO) environment and acts as a liaison to study leadership and sponsor(s). The individual ensures study activities are meeting deadlines and manages overall study timeline. Provides oversight and mentoring to more junior Clinical Project Coordinators on the study team in addition to managing Clinical Project Coordinators in a supervisory capacity.

Essential Functions
• Independently direct the development and execution of clinical trial activities for multi-center NIH and industry sponsored clinical trials, including developing and revising study timelines. Engage with Finance for budget development and budget management. May be asked to manage more complex protocols and/or larger scale industry sponsored trials.
• Oversee study supplies purchasing and inventory, study sample inventory and transfer between study sites. Liaise with data management team to ensure reliable and accurate specimen and clinical data collection.
• Oversee and engage in study subject recruitment, sample collection, study subject compensation, communication with bedside team for study procedures.
• Mentor, train and manage more junior Clinical Project Coordinators as part of a project team. In addition, manage other Clinical Project Coordinators in a managerial capacity, including developing career plans and delivering performance appraisals.
• Lead internal and external meetings and provide professional direction within the clinical research coordination team. Monitor progress toward meeting team goals and completing action items.
• Oversee entire study team, internal and external, including clinical research sites (average 3 per trial), clinical and research laboratories, study medical monitors, biostatistics core, and data management team.
• Draft and/or complete internal review of study protocol and final study documents for review and approval by study leadership. Draft requests and reports to regulatory agencies (e.g., MTA, DUA, IND application, annual IND update to FDA, etc.).
• Plan large scale external meetings. Present at external study meetings as well as other professional meetings.
• Other duties as assigned.

Minimum Education & Experience
• Bachelor's degree required with major coursework in appropriate health, social science, or biological science field.
• Master's degree preferred.
• 6 years of relevant experience with clinical trials or equivalent combination of education and experience required.
• Previous personnel management experience.
• Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials.

Knowledge, Skills and Abilities
• Strong communication skills, interpersonal skills, attention to detail and organization required.

Licenses and Certifications
• Laboratory Safety (Biological/Chemical) Training, Clinical research professional/project management certification upon hire preferred.

EEO Statement

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.