Managed early-phase clinical trials in oncology, respiratory, nephrology, and medical devices from initiation to closure, including a global Phase 3 infectious disease trial.Supported operational activities related to site evaluation, activation, initiation, monitoring, and close-out, ensuring compliance with study timelines and GCP.Oversaw site selection, feasibility assessments, and budget negotiations for global trials, acting as the main point of contact for clinical sites to ensure protocol adherence and timely trial execution.Conducted regular site calls to ensure sites are on track and promptly addressed issues.Assisted with study site activation activities, including registering investigator sites and collaborating to complete essential documents such as Investigator Initiation Packages (IIP) and study contracts.Managed the electronic Trial Master File (eTMF) for audit readiness and document accuracy, enhancing clinical trial efficiency by leveraging advanced proficiency in electronic spreadsheet management for budget tracking and site activation documentation.Assisted sites in data query management and supported CRAs with site visits, training, documentation, and expense management.Facilitated regulatory submissions, ensuring compliance with timelines and securing timely approvals.Monitored study timelines, tracked milestones, and coordinated cross-functional team communication.Managed vendors for clinical supplies, including shipments, inventory, and reconciliations.Assisted with budget tracking, invoice processing, and Change Order management for out-of-scope activities.Conducted quality control of study files and prepared for audits to ensure compliance.Maintained meeting agendas, minutes, and action items, presenting trial updates to sponsors.Collaborated with data management to ensure accurate data collection and documentation of deviations.

Managed 23 clinical trial projects (Phases I-IV) across oncology, dermatology, neurology, and respiratory studies, coordinating more than 100 clinical sites to ensure compliance with GCP/ICH guidelines from initiation to closure.Set up, tracked, and maintained essential study activities and supplies, including regulatory documents, contracts, and grant payments, as well as in-house management of documentation from clinical sites.Coordinated site activation activities, ensuring the timely initiation of clinical sites, including overseeing the submission and tracking of regulatory documents within eTMF/LSF for audit readiness. Coordinated with project teams for the distribution, retrieval, and review of regulatory documents required for trial initiation, streamlining processes using SharePoint and Gibraltar, and further enhancing efficiency with payment systems such as TCP Easy Invoice and CAPRIA. Generated grant payment requests, maintained tracking tools for each study, and resolved payment inquiries from investigator sites.Supported study timelines by establishing a systematic process for clinical trial supply delivery from the sponsor's office to sites, ensuring timely delivery of study materials and promptly processing site requests for shipping supplies as needed.

Demonstrate knowledge of ALCOA-C and RUTOLA-TMF principles on all trial related documents, including essential documents while placing and reviewing document in the TMF system.Awareness and Utilization of the TMF Reference Model on applicable studiesVerify the acceptability of submitted TMF documents as per applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements.Upload, apply naming conventions, and input correct metadata within the Fusion eTMF modulePerform 2nd pass activities against relevant parameters to ensure that the documents uploaded into the eTMF are fully acceptable and approved for the TMF.

surgical management of diseases related to oral cavity/face.