Sr. Clinical Trial Manager

About the role

The Sr. Clinical Trial Manager (Sr. CTM) is a hands-on program owner responsible for the end-to-end execution of assigned clinical studies within a portfolio spanning US IDE pivotal trials, registries, and international (OUS) studies. Reporting to the Sr. Director of Clinical Affairs, the Sr. CTM leads studies from start up through closeout, managing timelines, budgets, sites, vendors, and data quality while leveraging CROs and contract monitors for field execution.

Responsibilities

• Own end-to-end execution of assigned clinical studies (IDE, registry, post-market, and international) from start-up through closeout, delivering each on time, on budget, and inspection-ready.
• Lead study start-up activities, including contributions to protocol, informed consent, and case report form development; site identification, qualification, and selection; and IRB/EC and regulatory submissions.
• Develop and maintain study documentation, including clinical/investigational plans, monitoring plans, training and recruitment materials, and study reports.
• Oversee monitoring performed by CROs and contract CRAs; review monitoring reports, resolve site issues, and conduct sponsor oversight or co-monitoring visits as needed.
• Establish and maintain the Trial Master File (TMF), and oversee EDC build, user acceptance testing, and data quality throughout the study lifecycle.
• Manage clinical supply forecasting, investigational device accountability, and site payment processes.
• Drive enrollment against plan; proactively identify and resolve barriers with sites and internal teams.
• Support Clinical Event Committee (CEC) and Data Safety Monitoring Board (DSMB) activities, and contribute to annual reports, safety reports, and study summaries for regulatory submissions.

Skills & Hands-On Experience

• Own end-to-end execution of assigned clinical studies (IDE, registry, post-market, and international) from start-up through closeout, delivering each on time, on budget, and inspection-ready.
• Lead study start-up activities, including contributions to protocol, informed consent, and case report form development; site identification, qualification, and selection; and IRB/EC and regulatory submissions.
• Develop and maintain study documentation, including clinical/investigational plans, monitoring plans, training and recruitment materials, and study reports.
• Oversee monitoring performed by CROs and contract CRAs; review monitoring reports, resolve site issues, and conduct sponsor oversight or co-monitoring visits as needed.
• Establish and maintain the Trial Master File (TMF), and oversee EDC build, user acceptance testing, and data quality throughout the study lifecycle.
• Manage clinical supply forecasting, investigational device accountability, and site payment processes.
• Drive enrollment against plan; proactively identify and resolve barriers with sites and internal teams.
• Support Clinical Event Committee (CEC) and Data Safety Monitoring Board (DSMB) activities, and contribute to annual reports, safety reports, and study summaries for regulatory submissions.