Sr. Clinical Trials Project Manager

Responsibilities

• Directs and coordinates all aspects of clinical research trials and acts as a liaison to study leadership and sponsor(s).
• Ensures study activities are meeting deadlines and manages overall study timeline.
• Provides oversight and mentoring to junior members of the study team.

Requirements

• 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.
• Helps coordinate work between entire study team, including clinical trial sites, clinical and research laboratories, study medical monitors, biostatistics core, and data management team.
• Represents study team in meetings and during training sessions with sites.
• Led internal study meetings and monitors progress toward meeting team goals and completing action items.
• Participates in planning external meetings, including development of agenda and meeting materials and may be required to present or report out on action items.
• Mentors, trains, and manages more junior staff 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, such as protocols, amendments, study plans, DSMB reports, grant submissions, and annual reports, for review and approval by study leadership.
• Drafts requests and reports to regulatory agencies, such as 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.

Qualifications

• Bachelor's degree and 5 years of relevant experience required.
• Master's degree preferred.
• Equivalent combination of education and experience may be considered.
• Previous personnel/study team management experience preferred.

Skills

• Strong communication skills.
• Interpersonal skills.
• Attention to detail.
• Organization skills.

Benefits

The University of Rochester offers a comprehensive benefits package including health insurance, retirement savings plan, and paid time off.

Pay

$70,600.00 - $105,800.00

Schedule

Full time