Senior Clinical Trial Manager

Peptilogics•Pittsburgh, PA

About The Position

Peptilogics is a surgical therapeutics company dedicated to curing and preventing devastating medical device-related infections (MDRI). Our lead candidate, PLG0206, is a first-in-class drug that targets biofilm, a protective bacterial matrix that is the root cause of device infections across surgical categories, and has no approved cure to date. PLG0206 is currently being evaluated in a Phase 2/3 registration trial for the treatment of prosthetic joint infection (PJI), the first of multiple potential indications to treat and prevent MDRI. 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.

Requirements

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

Nice To Haves

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

Responsibilities

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