Full-Time Senior Clinical Project Manager

Senior Clinical Project Manager reports directly to the Director Clinical Affairs and plays a critical role within TMC.

Responsibilities

• Lead all Company clinical research projects (strategy, execution, budget).
• Work closely with marketing, KOLs, physicians, and clinical research operations.
• Manage all aspects of clinical studies, including feasibility assessment and execution plan recommendations.
• Develop and manage study timelines and metrics.
• Select and manage external vendors, developing specifications.
• Review vendor reports, budgets, and metrics.
• Prepare and present project debriefings.
• Plan, execute, and lead study-specific meetings.
• Manage/participate in site-monitoring visits.
• Monitor and drive study enrollment, site screening, and initiations.
• Interact with monitoring and data management organizations.
• Possible involvement in FDA submissions.
• Manage multiple clinical studies and teams.
• Identify clinical sites and build relationships with Principal Investigators.
• Work with customers to validate product clinical value.
• Support clinical research procedures.
• Develop protocols, informed consent forms, and study documents.
• Prepare IRB submissions.
• Ensure study implementation (site staff training, data collection, progress).
• Perform monitoring visits (qualification, initiation, interim, close-out).
• Review and approve monitoring visit letters and reports.
• Perform data analysis, generate reports, and archive data.
• Provide feedback to product management for User Requirements.
• Create and track clinical study plans and budgets.
• Ensure compliance with regulations (FDA, ISO, ICH, GCPs).

Requirements

• Bachelor's degree
• 7 years experience as Clinical Research Associate, actively monitoring clinical research projects.
• 7 years experience as Program/project manager, process improvement in clinical research or healthcare.
• Experience with MS Project, Smart Sheets, project management techniques and tools, Excel, PowerPoint, and Word.
• Project Management Professional (PMP) or similar certification (preferred).

Other

• All information kept confidential according to EEO guidelines
• Treace's Privacy Policy applies
• Treace does not discriminate against applicants or employees.
• EEO/Disabled/Veterans Employer
• Treace is a drug-free employer

What is the last date for applying to the job?

Which countries are accepted for this remote job?