Clinical Trial Manager

Responsibilities

• Manage all aspects of clinical trials including vendor management, CRO oversight, and coordination of study service providers.
• Lead or support cross-functional study teams with focus on Clinical Operations deliverables and study execution.
• Track and report study milestones, metrics, and timelines to leadership.
• Ensure studies adhere to ICH GCP, applicable regulations, protocols, and SOPs.
• Assist in preparation and review of clinical trial documents including protocols, informed consent, monitoring plans, project plans, CRFs, and study reports.
• Partner with eTMF team to establish and maintain TMF with periodic reviews.
• Coordinate and support resolution of audit findings and maintain audit-ready documentation.
• Identify and resolve clinical project issues and contribute to process improvements.
• Assess operational feasibility, recommend study execution plans, and support site selection.
• Negotiate and finalize site contracts and budgets.
• Perform and manage ongoing data review.
• Oversee site visits including qualification, initiation, monitoring, and close-out as needed.
• Review monitoring reports to ensure quality and resolve site issues.
• Track and review protocol deviations and assess impact on data.
• Review and approve clinical invoices against approved scopes of work.
• Forecast and oversee clinical supplies including study drug and materials.
• Provide service provider oversight, identify issues, and escalate as appropriate.

Requirements

• Bachelor’s degree with 3 to 5 years of experience in core clinical operations functions such as trial management, site management, and monitoring oversight.
• Strong communication skills.
• Self-motivated with ability to prioritize, shift, and manage multiple tasks in a fast-paced environment.
• Residence in Eastern or Central time zones.