Clinical Trial Lead

Clinical Trial Lead will provide direction and guidance to the project team, coordinating site management and monitoring activities, and communicating status of these activities to the Project Manager.Responsibilities may include, but are not limited to;Start-upSupport and coordinate feasibility, site identification, and site selection activities for multi-regional studiesLead and assist with preparation of initial ethics and regulatory submission package and oversight on approval processes and timelinesSupport PM with application and tracking Investigational Product (IP)Ongoing/monitoring phaseLead internal CRA meetings/teleconferences and may be required to prepare for the meeting, presenting a section of the agenda and task follow upMay attend Sponsor meetings and contribute as required and assist with preparing the agendaCorrespond directly with the sponsor to provide information/updatesAdvanced clinical monitoring and site management responsibilitiesOperating at a senior level with clear accountability for trial delivery, timelines, and qualityLeading clinical teamsCoaching and mentoring CRAs/clinical staffManaging performance, quality issues, and delivery expectationsQualificationsMust have performed advanced clinical monitoring tasks and site management tasks across multiple locations at a senior level and demonstrated effective leadership, organization skills, communication skills, and the ability to meet deadlines in a fast and dynamic environment.Prior hands‑on CRA experienceMinimum 3-5 years of experience as a Clinical Lead, Clinical Trial Manager, or equivalent roleEvidence of line or functional leadership (e.g., managing through enrollment delays, site activation delays, sponsor shifting priorities)Experienced in coaching and mentoring clinical teams.Good communication skills and fluency in both verbal and written EnglishAdvanced clinical monitoring and site management responsibilitiesOperating at a senior level with clear accountability for trial delivery, timelines, and qualityExperience working in fast‑paced, deadline‑driven environments with competing prioritiesHybrid - Raleigh, NC