FEFA LLC is seeking a Data Scientist for a remote position. This position will assist in designing, building and maintaining clinical studies databases using electronic data capture platforms and generating required documentation related to data management, while ensuring compliance with GCPs, FDA regulations and SOP requirements. This person will work directly with clinical data analysts and clinical study managers to provide input for all data management related activities.

Responsibilities:

• Support the completion of all Clinical Data Management owned deliverables in order to achieve defined business goals;
• Participate in designing and building of clinical studies database using electronic data capture platforms;
• Design, manage and document required database validation (user acceptance testing);
• Proactively organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, and quality issues;
• Generate and maintain all required documentation related to database release, maintenance and closure, including database specifications, validation efforts, database release, edit check procedures, import/export setup, and processing;
• Assist with the development of Data Management Plans, Data Entry Guidelines and database training documentation;
• Train clinical centers on quality clinical data capture;
• Manage database user access;
• Ensure proper closeout and archiving of data management study related materials, i.e. database change documentation, validation documents, and final patient casebooks in paper or electronic format;
• Build effective working relationships with team members

• Bachelor's or Associate's Degree
• Minimum of one to three years of related experience, ideally in a clinical research environment.
• Understanding of the use of electronic database tools, systems, and coding dictionaries.