Senior Clinical Database Programmer

At eClinical Solutions, our goal is to leverage technology to accelerate clinical research and bring life-changing therapies to patients faster. Our industry-leading elluminate® clinical data platform is used by top life sciences companies worldwide to regain control of their data and provide meaningful analytical insights. 

You will make an impact:

As a Senior Clinical Database Programmer, you will be responsible for delivering quality EDC trial configurations for clients leveraging Medidata Rave platform. You will perform configuration for the EDC projects. In addition, as the Senior Clinical Database Programmer you will perform Quality Control of configured projects for activities that they did not perform the development/configuration. You will also provide consulting services that may include user acceptance testing (UAT) of EDC systems, global library/standards development, and report quality control.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. 

Your day to day:

• Design specifications of EDC Trial Build services for core configuration, eCRFs, data validations (DVS) and reporting
• Develop configuration of the EDC trial by utilizing the trial design specifications for eCRFs, DVS, custom functions integrations and reporting

• Advise clients on best practices for clinical database builds, eCRF layout and compliance with CDISC standards
• Implement and perform data integrations related activities to ensure data integrations meet client requirements
• Collaborate with the project team to ensure data can be extracted easily from the back end to support efficient downstream reporting and analysis
• Collaborate with the project team to ensure the configuration is completed on time with high quality
• Provide Quality Control on deliverables developed by other team members

• Maintain all required Configuration Specifications and Quality Control documents as required by SOP and Processes
• Collaborate with training team as an EDC Subject Matter Expert and perform training
• Work on consulting efforts related to EDC systems including UAT, global library/standards development
• Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures

Take the first step towards your dream career. Here is what we are looking for in this role. 

Qualifications:

• Bachelor's degree preferred, analytic discipline a plus (Computer Science or Health related field) and/or equivalent work experience

• 7+ years in Pharmaceutical/Biotechnology industry desired
• Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and CDISC standards (CDASH, SDTM)

• 5+ years' experience working with Medidata Rave platform
• Custom Functions programming experience using C#
• Experience with Database programming is a plus: Oracle, SQL Server

• Familiarity with EDC Systems: InForm or Oracle Clinical
• Experience with Business Intelligence Tools: Business Objects, JReview, Cognos, or related

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.