Senior Clinical Trial Manager

Senior Clinical Trial Manager

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.

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

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

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

Peptilogics is proud to be an equal opportunity employer. We make hiring decisions based on qualifications, experience, and potential, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status. We welcome candidates from all backgrounds to apply.