eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate®, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

OVERVIEW

Clinical Database Programmers are responsible for delivering quality EDC trial configurations for clients. Clinical Database Programmers will perform configuration for the EDC projects. In addition, EDC Developers will perform Quality Control of configured projects for other Clinical Database Programmers for those activities that they did not perform the development / configuration. Clinical Database Programmers will also provide consulting services that may include user acceptance testing (UAT) of EDC systems, global library / standards development, and report quality control.

This position reports to a management position of the Professional Services Team.

KEY TASKS & RESPONSIBILITIES

• Develop and build basic components of clinical databases, including forms and folders, matrices, data dictionaries and unit dictionaries.
• Program basic and advanced edit checks and derivations.
• Understand and be able to work with and update existing custom functions for minor programming requests and updates.
• Understand basic functionality of Medidata Rave databases, and work with data management and other team members to review and provided feedback on specifications documents and other documents such as UAT and Production logs.
• Provide Quality Control on deliverables developed by other team members
• Other duties as assigned

CANDIDATE’S PROFILE

Education Experience:

• Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field) and/or equivalent work experience
• Minimum 3 years in Pharmaceutical/Biotechnology industry or equivalent
• Familiarity with EDC Systems: Rave, InForm, or Oracle Clinical preferred; previous experience designing eCRFs and edit checks
• Experience with Data Reporting Tools: Business Objects, JReview, Cognos, or related preferred

Professional Skills:

• Minimum 3 years in Pharmaceutical/Biotechnology industry or equivalent
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent knowledge of English; verbal and written communication skills
• Excellent team player

Technical Skills:

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• 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 industry standards (CDASH, SDTM) preferred
• Familiarity with Databases: Oracle, SQL Server

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 qualifications, merit, culture fit and business need.