- Responsible for all activities of clinical study data management including CRF design, database and edit check development, query generation/processing, reconciliation of CRF and electronic data, and database cleaning activities.
- Assist in the planning and implementation of the data management portions of research and clinical studies. Develops systems for organizing data to analyze, identify and report trends.
- Work with R&D staff, CRAs, and statistical department to provide accurate data acquisition and to furnish accurate and well-documented study databases.
- Responsible for timely identification of problems or issues that could affect the results or timely completion of the study, or any protocol deviations, and for suggesting mechanisms for solving the problem.
- Bachelors degree is required. Bachelor in a Scientific Discipline is highly preferred.
- Minimum 2 to 5 years clinical data management experience supporting clinical trials in a pharmaceutical, medical device, or biotech company.
- Excellent analytical, problem-solving, organizational, time-management, interpersonal and communication skills.
- Proficient with Microsoft Access.
- Adept at learning new databases.
- General knowledge of FDA regulations
- Experience with web-based Electronic Data Capture (EDC) systems
- Good understanding of medical terminology, human physiology and laboratory testing preferred.