Clinical Study Manager

Summary

Join our team as a Clinical Study Manager (CSM) and oversee the entire lifecycle of clinical trials, from planning and design to execution and close-out. You will lead cross-functional teams, manage budgets and timelines, ensure compliance with regulatory requirements, and maintain high-quality data. Responsibilities include scientific research, protocol development, site selection, vendor management, issue resolution, and regulatory documentation. The ideal candidate possesses a Bachelor's degree in life sciences (advanced degree preferred), 3-5 years of research experience (at least 2 years in study management), and strong knowledge of ICH-GCP and other relevant guidelines. Excellent organizational, communication, and leadership skills are essential. This role requires expertise in project management, stakeholder management, and conflict resolution.

Requirements

• Bachelor’s degree in life sciences or related field (advanced degree preferred)
• Minimum 3-5 years of research experience, with at least 2 years in a study management role
• Knowledge of ICH-GCP, FDA, EMA, and other relevant regulatory guidelines
• Attention to detail and ability to manage multiple tasks
• Strong organizational and communication/collaboration skills
• Project management and leadership
• Communication and stakeholder management
• Conflict resolution, problem-solving and risk mitigation
• Familiarity with clinical trial management systems and related tools

Responsibilities

• Oversee the planning, execution, and close of clinical trials to ensure they are successful and conducted in compliance with regulatory requirements, study protocols, and company standards
• Performs research to inform study design
• Collaborates with cross-functional teams and domain experts to develop clinical protocols
• Conducts feasibility assessments and selects suitable clinical sites and investigators
• Helps create and manage study budgets and timelines
• Identifies CROs, labs, and other vendors to be used in study
• Leads daily operations of assigned clinical studies, ensuring adherence to the protocol and regulatory requirements (e.g., GCP, ICH)
• Identifies risks or issues during the trial and implements corrective actions
• Leads and coordinates cross-functional study teams including Clinical Operations, Data Management, Biostatistics, Regulatory, and Safety
• Organizes and leads study team meetings, ensuring clear action items and follow-ups
• Coordinates the preparation and submission of documents to regulatory authorities (e.g., INDs, CTAs, amendments)
• Works with data teams to identify criteria for cases and processes for collection
• Works with data teams to ensure timely and high-quality data capture, including QC / QA as needed
• Ensures the trial is always ready for audits or inspections by maintaining accurate and complete documentation
• Coordinate data analyses and review results
• Supports preparation of the final clinical study report
• Oversees close-out visits and site document archiving