Regulatory Affairs & Clinical Data Manager

A company is looking for a Regulatory & Clinical Data Operations Manager. Key Responsibilities Prepare and submit regulatory documentation, managing compliance with FDA and other certifications Serve as Clinical Research Associate (CRA) and manage healthcare datasets for clinical studies Coordinate cross-functional teams to ensure timely project execution and compliance Required Qualifications Bachelor's or Master's degree in Life Sciences, Health Informatics, Regulatory Affairs, Data Science, or a related field Minimum of 1 year of experience as a Clinical Research Associate (CRA) 2-5 years of regulatory experience, including FDA submissions and ISO standards Proven experience managing EMR data and familiarity with the US healthcare system Strong proficiency in data management tools and visualization platforms

Jun 12, 2025 - 09:10

A company is looking for a Regulatory & Clinical Data Operations Manager. Key Responsibilities Prepare and submit regulatory documentation, managing compliance with FDA and other certifications Serve as Clinical Research Associate (CRA) and manage healthcare datasets for clinical studies Coordinate cross-functional teams to ensure timely project execution and compliance Required Qualifications Bachelor's or Master's degree in Life Sciences, Health Informatics, Regulatory Affairs, Data Science, or a related field Minimum of 1 year of experience as a Clinical Research Associate (CRA) 2-5 years of regulatory experience, including FDA submissions and ISO standards Proven experience managing EMR data and familiarity with the US healthcare system Strong proficiency in data management tools and visualization platforms