Clinical Study Manager

A Clinical Study Manager at a lead level typically possesses extensive experience in overseeing and managing clinical trials from initiation through completion. This role requires strong expertise in clinical research methodologies, study design, protocol development, and regulatory compliance. The candidate should have a solid understanding of Good Clinical Practice (GCP) guidelines, FDA regulations, and other relevant international standards to ensure studies meet ethical and legal requirements. Proven leadership skills are essential, including the ability to coordinate cross-functional teams, manage timelines, budgets, and resources effectively, and resolve complex issues that arise during study conduct. Experience with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and other clinical research technologies is often required to facilitate data collection, monitoring, and reporting. Strong communication skills are necessary to liaise with investigators, sponsors, vendors, and regulatory authorities. A bachelor’s degree provides a foundational knowledge base in life sciences or a related field, supporting the technical and scientific understanding required for this role. The lead experience level and significant experience points indicate a candidate capable of independently managing multiple studies or large-scale projects, mentoring junior staff, and contributing to strategic planning and process improvements within clinical operations. Overall, the Clinical Study Manager combines scientific expertise, project management proficiency, regulatory knowledge, and leadership capabilities to ensure successful execution and delivery of clinical research programs.