Position Overview
The Senior Database Programmer is responsible to carry out database design related activities independently to support clinical projects. The activities include, but are not limited to, design of Case Report Forms (CRFs) and clinical databases, supporting data management related reports and listings, and programming edit checks in Electronic Data Capture (EDC) systems.
Primary Responsibilities
To perform this job successfully, incumbent must be able to satisfactorily perform the essential functions of the role without or with reasonable accommodations. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Functions:
● Design and develop the configuration of EDC systems for clinical trials.
● Design, implement, and maintain clinical databases, including Clinical Data Interchange Standards Consortium (CDISC) compliant databases.
● Lead in design CRF/eCRFs based on protocol or CRF specification.
● Review the User Acceptance Test (UAT) specification document. Oversee the UAT process.
● Set up the EDC System Security (granting/restricting rights to certain users and processes and maintain the EDC user accounts database.
● Write SAS codes to generate data management-related reports, listings and edit checks, as needed.
● Program and maintain edit checks in EDC systems.
● Perform post go-live changes in EDC systems.
● Perform data extractions from EDC systems.
● Perform site support by answering phone calls or responding to emails and EDC training as needed.
● Represented the company in interfaces with clients and regulatory agencies globally.
Qualifications Including Education, Experience, and Skills
● Bachelor's Degree in Computer Science, life science or related field or equivalent defined as a minimum of 5 years related, combined experience in employment, education, knowledge, and skills that will enable the incumbent to proficiently perform the duties of the role is required. Master’s Degree is preferred.
● Minimum 3 years clinical trial experience with clinical data management.
● Minimum 3 years experience with Medidata Rave EDC
● Knowledge of database programming, relational database systems, or statistical packages.
● Should be highly organized, and capable of handling multiple projects or tasks effectively.