Principal Clinical Database Programmer - Remote

Overview

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

In Short

• Validates specification to development through leading team review, co-programmer review, and User Acceptance Testing
• Perform User and Site Administration to include site set up and assignment of roles, permissions, and eLearning requirements
• Responsible for the development, maintenance, and compliance of complete database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules and Standard/Custom Reports
• Serves as a contact/resource for Process/Standards development and implementation including best practices to improve quality and streamline database build and data cleaning efforts
• Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams, and other stakeholders
• As SME is responsible to provide escalation of study specific functional issues, application/vendor issues, testing and validation needs, enhancement requirements, custom functions and/or custom reporting
• May lead teams and/or supervise other programmers and serve in a project management capacity for programming projects.
• Support development and review of SOPs, and Work Guidelines to promote consistency and identify additional opportunities for standardization and departmental efficiency
• Other duties as assigned

Requirements

• Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field)
• 7+ years in Pharmaceutical/Biotechnology industry or equivalent, preferably in Services or Consulting role preferred
• Ability to work creatively and independently to carry out assignments of a complex nature
• Ability to communicate and work effectively and cooperatively with other professional staff members
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent knowledge of English; verbal and written communication skills
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Experience with requirements gathering, design and specification development of CRFs, edit checks, site queries, and understanding of database structures and programming languages
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology preferred
• Expert knowledge of Medidata Clinical Cloud (MCC) especially Rave EDC capabilities and best practices
• Familiarity with Clinical Systems and technologies: ePRO, IVRS/IWRS, CTMS

Benefits

• Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
• eClinical is a winner of the 2023 Top Workplaces USA national award!
• We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience.
• eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business.
• We are proud to be an equal opportunity employer that values diversity.