Clinical Trials Program Manager

Overview

SUMMARY: Reporting to the Divisional Research Director or Chief at Brown University Health, the Clinical Trial Program Manager will lead and oversee the initiation and execution of clinical trials, ensuring that all activities are conducted in compliance with regulatory requirements, company policies, and standard operating procedures (SOPs). They will oversee the activation process from start to finish, including interactions with sponsors, Contract Research Organizations (CROs), External Vendors, Institutional Review Boards (IRBs) and internal staff and external departments.

This process is performed in collaboration with the Principal Investigator, study team members, and other relevant personnel. They will act as a liaison between different central departments and research teams throughout the lifecycle of the clinical study. They maintain real-time tracking of progress and milestones and proactively alert to potential delays; responsible for confirming all institutional requirements are met prior to activation implementation.

This role leads the study process from site/PI identification through site activation, readiness for trial execution, execution, and closure, and includes supervisory responsibilities for mentoring, training and supervising a team of research nurses, coordinators, and assistants. The role also implements quality control measures, evaluates and enhances processes and systems and collects and reports data to internal and external stakeholders. It also oversees the development of study budgets and contracts in collaboration with cross-functional teams.

Brown University Health employees are expected to model the organization s values of Compassion, Accountability, Respect and Excellence, and to demonstrate the core Success Factors:
Instill Trust and Value Differences, Patient and Community Focus, and Collaboration. Leaders should demonstrate the aptitude to Ensure Accountability, Build Effective Teams, Drive Vision and Purpose, and Optimize Work Processes to achieve strategic goals.