What are the responsibilities and job description for the Clinical Research Operations Manager position at Monopar Therapeutics Inc.?
As a Clinical Research Data Scientist at Monopar Therapeutics Inc., you will play a critical role in supporting the advancement and filing of a New Drug Application for our late-stage rare disease program.
Responsibilities
- Contribute to the development of program regulatory and market initiatives.
- Review and analyze data objectively to lead the team toward recommendations that highlight opportunities, address potential risks, and proactively provide appropriate mitigations.
- Develop and apply quantitative models to analyze clinical trial data, patient outcomes, and real-world evidence.
- Analyze and interpret clinical outcomes, safety, and other program data into clear and concise summaries, diagrams, and presentations.
Requirements
- Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field).
- A minimum of 5 years of experience in data management and/or research with a focus within the biotechnology industry.
- Knowledge of FDA and ICH guidance documents and regulations.
- Experience supporting a successful New Drug Application.
