Position Overview

The Senior Clinical Trial Manager (Sr CTM) oversees the planning, execution, and completion of Peptilogics' clinical trials to ensure they meet regulatory standards, timelines, and budget constraints, with current focus on the RETAIN Phase 2/3 registrational trial of PLG0206 in prosthetic joint infection (PJI). Reporting to the Director, Clinical Operations, the Sr CTM oversees CROs and trial vendors with a focus on ensuring project and program objectives are met, and is pivotal in ensuring the integrity and success of clinical research studies.

Essential Functions

• Manage day-to-day operations of clinical trials, working closely with both the internal cross-functional study team and the CRO team members
• Facilitate internal team meetings to provide study status updates
• Serve as the CRO's primary point of contact for all day-to-day activities, including study startup, monitoring, site management, and close-out activities
• Anticipate project needs and take decisive action in service of the project
• Monitor, track, and report site and study performance metrics, budget, and timelines; keep updated weekly at a minimum
• Review with the Clinical Operations team and take needed steps to ameliorate issues when needed
• Review monitoring trip reports and provide feedback to the CRO as needed
• Ensure compliance with Good Clinical Practice (GCP), ICH, and regulatory requirements
• Serve as the primary point of contact for select clinical trial vendors, ensuring deliverables are complete, high quality, and provided on time
• Provide regular updates and reports to stakeholders
• Review TMF files to ensure the TMF is complete and inspection-ready
• Ensure study operations are compliant with study plans
• Collaborate with the internal study team and CRO teams to prioritize data integrity and participant safety
• Continuously monitor for quality issues and implement quality-control measures as needed in a timely manner, consulting with relevant internal team members
• Assist with study-level budgetary reviews, assessments, and analysis
• Travel as required (20-30%), depending on program stage
• Perform other duties as assigned

Required Qualifications and Skills

• Strong, clear communication, including direct verbal interaction with Investigators and site study-team members as needed; comfortable asking for prioritization support when needed
• Strong organization skills and ability to follow through on a task to completion
• Prioritization and organizational skills that flex and adapt in real time, independently, as the clinical trial landscape evolves
• Thrives in a fast-paced environment that rewards independent thinking and nimble action
• Proactive, can-do approach to assignments and responsibilities; instills the same across internal and external study teams
• Comfortable asking questions and driven to get answers and explanations as part of continual learning
• Ability to hold team members and self accountable for deliverables critical to the project's success
• Demonstrated experience managing CRO relationships, trial timelines, and study budgets in a sponsor or CRO environment
• Proficiency in clinical trial management systems and Microsoft Office applications
• Bachelor's degree in life sciences, health sciences, or a related field; advanced degree preferred
• Minimum of 12 years of clinical research experience, with demonstrated experience in multicenter/multinational late-stage clinical trial management
• Working knowledge of GCP, FDA regulations (including 21 CFR Part 312), and ICH guidelines

Desirable Qualifications and Skills

• Professional certification (e.g., CCRP, CCRA, or PMP)
• Prior experience supporting clinical-stage biotech or startup environments
• Experience with hospital-based clinical trials
• Experience with international/multinational trials
• Experience with Smartsheet