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 contribute to the successful completion of clinical studies. Responsibilities include study planning and design, trial management and oversight, cross-functional coordination, data and quality management, and study analyses and close-out. The ideal candidate will possess a Bachelor's degree in life sciences or a related field, along with 3-5 years of research experience, including at least 2 years in a study management role. A strong understanding of ICH-GCP, FDA, EMA, and other relevant regulatory guidelines is essential. Excellent organizational, communication, and leadership skills are also required.

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

• Perform research to inform study design
• Collaborate with cross-functional teams and domain experts to develop clinical protocols
• Conduct feasibility assessments and select suitable clinical sites and investigators
• Help create and manage study budgets and timelines
• Identify CROs, labs, and other vendors to be used in study
• Lead daily operations of assigned clinical studies, ensuring adherence to the protocol and regulatory requirements (e.g., GCP, ICH)
• Identify risks or issues during the trial and implement corrective actions
• Lead and coordinate cross-functional study teams including Clinical Operations, Data Management, Biostatistics, Regulatory, and Safety
• Organize and lead study team meetings, ensuring clear action items and follow-ups
• Coordinate the preparation and submission of documents to regulatory authorities (e.g., INDs, CTAs, amendments)
• Work with data teams to identify criteria for cases and processes for collection
• Work with data teams to ensure timely and high-quality data capture, including QC / QA as needed
• Ensure the trial is always ready for audits or inspections by maintaining accurate and complete documentation
• Coordinate data analyses and review results
• Support preparation of the final clinical study report
• Oversee close-out visits and site document archiving