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Sr Clinical Trials Project Mgr

$70,197 - $105,295/Yr

University of Rochester - Rochester, NY

posted 2 months ago

Full-time - Mid Level
Rochester, NY
Educational Services

About the position

The Senior Clinical Trials Project Manager at the University of Rochester plays a pivotal role in planning, directing, and coordinating various phases of clinical trials, including those initiated by the FDA, NIH, and other investigators. This position carries extensive responsibilities, particularly in supervising staff and ensuring compliance with regulatory requirements throughout the study lifecycle, from startup to closeout. The role requires a high degree of independent judgment and initiative, as the manager will oversee the operational aspects of clinical trials, ensuring that all objectives are met within the prescribed timelines and funding conditions. In this capacity, the Senior Clinical Trials Project Manager will implement study management strategies for research projects, ensuring that all activities align with the project's goals. This includes organizing and leading team meetings, monitoring study operations for compliance with government regulations, and preparing necessary documentation such as study protocols, consent forms, and standard operating procedures (SOPs). The manager will also coordinate training for investigators and study coordinators at participating centers, ensuring that all personnel are well-equipped to meet the study's demands. Additionally, the role involves developing and maintaining a comprehensive data management system in collaboration with IT staff, which includes creating electronic case report forms (eCRFs) and assisting with data collection and analysis. The Senior Clinical Trials Project Manager will also engage in regular evaluations of enrolling centers and maintain communication with sponsors, regulatory agencies, and university administration to ensure smooth project execution. The position requires a strong foundation in cardiovascular research literature and regulatory compliance, which the manager will enhance through ongoing education and participation in national meetings. Overall, this role is critical in ensuring the successful execution of clinical trials, contributing to the advancement of medical research and patient care.

Responsibilities

  • Plans and implements study management for research projects to ensure objectives are accomplished according to priorities, time limitations, and funding conditions.
  • Supervises study operations to comply with government reporting and funding regulatory requirements, including preparation of study activities, protocols, consents, SOPs, INDs, and IDEs.
  • Coordinates administrative efforts and trains investigators and coordinators at participating centers, supervising on-site monitoring if applicable.
  • Plans and implements a comprehensive data management and information system in conjunction with IT/computer programming staff, developing eCRFs and assisting with data collection and analysis.
  • Initiates and participates in meetings, evaluates enrolling centers, and confers with sponsors, agencies, IRBs, and university administration.
  • Hires, trains, supervises, and evaluates CCRC staff regarding performance and study responsibilities.
  • Maintains a good working knowledge of cardiovascular research literature and regulatory compliance issues through attendance at national meetings and interactions with study sponsors.

Requirements

  • Bachelor's degree in health, social science, or biological science field or equivalent combination of education and experience required.
  • Advanced degree in a relevant field preferred.
  • Minimum of 5 years of experience with clinical trials required.
  • Previous personnel/study team management experience preferred.
  • 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.

Benefits

  • Competitive salary range of $70,197 - $105,295 annually based on experience and qualifications.
  • Comprehensive health insurance coverage.
  • Retirement savings plan options.
  • Opportunities for professional development and continuing education.
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