Sr Clinical Trials Project Mgr

QUALIFICATIONS:

• Bachelor’s degree required with major course works in appropriate health, social science, or biological science field or equivalent combination of education and experience.
• Advanced degree in appropriate health, social science, or biological science field or equivalent combination of education and experience preferred.
• Minimum of 5 years of experience with Clinical Trials required.
• Previous personnel/study team management experience preferred.
• Clinical Trials Project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of Clinical Trials required.
• Strong verbal and written communication skills, interpersonal skills, attention to detail and organization required.
• Clinical research professional/project management certification preferred.
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GENERAL PURPOSE:

The Clinical Project Lead directs and coordinates all aspects of multi-center international clinical research trials in a Contract Research Organization (CRO) environment and acts as a liaison to study leadership and sponsor(s). 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.

JOB DUTIES AND RESPONSIBILITIES:

• 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.
• Oversees entire study team, including clinical trial sites (average 20 per trial), clinical and research laboratories, study medical monitors, biostatistics core, and data management team.
• Represents study team in meetings and during training sessions with sites.
• Leads internal study meetings and monitors progress toward meeting team goals and completing action items.
• Participates in planning larger scale external meetings, including development of agenda and meeting materials.
• Mentors, trains and manages more junior Clinical Project Coordinators 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 (e.g., protocols, amendments, study plans, DSMB reports, grant submissions, annual reports) for review and approval by study leadership.
• Drafts requests and reports to regulatory agencies (e.g., 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.
  Other duties as assigned.