About the role

Senior Clinical Database Developer designing and maintaining clinical study databases for global medical device trials. Collaborating across teams to ensure compliance and data integrity while mentoring junior staff.

Responsibilities

Design, develop, document, test and/or support clinical study databases and configuration of cross-system interfaces per business process
Drive the design, development, testing, and/or maintenance of custom clinical reports and dashboards, clinical data transfers, or other components related to clinical studies
Lead programming, testing, and documenting of study edit checks and validations
Partner as clinical technical specialists in the planning, designing, and implementing of clinical applications
Provide technical consultation on, and task directions for vendors
Mentor junior team members
Stay current on technologies, methods, standards, and best practices as well as trends and direction of the clinical data management industry.

Bachelor’s degree in computer science, Life Sciences, Engineering, or a related field (or equivalent experience)
Bachelor’s degree with a minimum of 8 years of experience in clinical database development/programming within medical device, pharmaceutical, or biotechnology environments, OR Master’s degree with a minimum of 6 years of experience in clinical database development/programming within medical device, pharmaceutical, or biotechnology environments.
Strong hands-on experience with Medidata Rave (study build, edit checks, UAT, reporting)
Demonstrated experience building EDC databases , programming edit checks and validations and supporting live clinical studies
Experience developing custom reports and dashboards for clinical trial oversight
Solid understanding of clinical trial processes and regulatory requirements (FDA, ICH-GCP)
Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills
Experience with BI/reporting tools (SAP Business Objects, Oracle Business Intelligence, Medidata Reporter, Looker, and/or SAS)
Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products)