Junior Project Manager - Clinical Research

The Junior Project Manager will support the planning, coordination, and monitoring of clinical research projects from initiation to completion. The role involves hands-on execution — including preparation of study documents, coordination with clinical sites, assisting with data collection and monitoring, and contributing to scientific writing. The position requires periodic travel to clinical sites for training, data collection, and monitoring activities. Assist in planning, execution, and monitoring of ongoing and upcoming clinical studies in alignment with project timelines. Prepare and maintain clinical documentation, including study protocols, informed consent forms, IRB submissions, case report forms (CRFs), Statistical Analysis plans (SAP) and ensure GCP/ICH and ISO 14155. Coordinate day-to-day communication between study sites, investigators, and internal teams. Participate in site selection, initiation, training, monitoring visits and close out to ensure protocol adherence and drive enrollment to plan using risk-based strategies. Implement data quality controls across EDCs and imaging. Maintain audit readiness with CAPA management and SOP stewardship aligned to the QMSTrack study progress, data entry, and milestones; flag any deviations or delays Support data management and quality assurance activities. Assist in scientific and regulatory writing (as required), including preparation of study reports, abstracts, and manuscripts. Maintain compliance with regulatory, ethical, and quality management system (QMS) requirements. Support orientation and supervision of interns or clinical technicians involved in research activities.

Good understanding of clinical research methodology and ethical practices. Exposure to protocol writing, IRB documentation, and data management preferred. Strong documentation, organizational, and analytical skills. Proficiency in Microsoft Office tools (Word, Excel, PowerPoint). Basic understanding of statistical analysis is an advantage.