Senior Clinical Trial Manager

Senior Clinical Trial ManagerThe 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 membersFacilitate internal team meetings to provide study status updatesServe as the CRO's primary point of contact for all day-to-day activities, including study startup, monitoring, site management, and close-out activitiesAnticipate project needs and take decisive action in service of the projectMonitor, track, and report site and study performance metrics, budget, and timelines; keep updated weekly at a minimumReview with the Clinical Operations team and take needed steps to ameliorate issues when neededReview monitoring trip reports and provide feedback to the CRO as neededEnsure compliance with Good Clinical Practice (GCP), ICH, and regulatory requirementsServe as the primary point of contact for select clinical trial vendors, ensuring deliverables are complete, high quality, and provided on timeProvide regular updates and reports to stakeholdersReview TMF files to ensure the TMF is complete and inspection-readyEnsure study operations are compliant with study plansCollaborate with the internal study team and CRO teams to prioritize data integrity and participant safetyContinuously monitor for quality issues and implement quality-control measures as needed in a timely manner, consulting with relevant internal team membersAssist with study-level budgetary reviews, assessments, and analysisTravel as required (20-30%), depending on program stagePerform other duties as assignedStrong, clear communication, including direct verbal interaction with Investigators and site study-team members as needed; comfortable asking for prioritization support when neededStrong organization skills and ability to follow through on a task to completionPrioritization and organizational skills that flex and adapt in real time, independently, as the clinical trial landscape evolvesThrives in a fast-paced environment that rewards independent thinking and nimble actionProactive, can-do approach to assignments and responsibilities; instills the same across internal and external study teamsComfortable asking questions and driven to get answers and explanations as part of continual learningAbility to hold team members and self accountable for deliverables critical to the project's successDemonstrated experience managing CRO relationships, trial timelines, and study budgets in a sponsor or CRO environmentProficiency in clinical trial management systems and Microsoft Office applicationsBachelor's degree in life sciences, health sciences, or a related field; advanced degree preferredMinimum of 12 years of clinical research experience, with demonstrated experience in multicenter/multinational late-stage clinical trial managementWorking knowledge of GCP, FDA regulations (including 21 CFR Part 312), and ICH guidelinesProfessional certification (e.g., CCRP, CCRA, or PMP)Prior experience supporting clinical-stage biotech or startup environmentsExperience with hospital-based clinical trialsExperience with international/multinational trialsExperience with SmartsheetPeptilogics 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.