[Hiring] Principal Clinical Database Developer @Emmes

Role Description

The Principal Clinical Database Developer (PCDD) is an expert in delivering high-quality electronic data capture (EDC) platform and clinical database study configurations. PCDDs work as an integral part of an agile team and serve as a lead consultant on activities such as:

• User acceptance testing (UAT) of EDC systems
• Data integration, upload, or transfer development
• Global library/standards development

Proficient in creating SQL-based or configuration-based data validation checks and provides expertise for implementing CDISC standards such as CDASH and SDTM within the EDC system. This individual is a technical subject matter expert on clinical database development issues and may serve as a Product Owner or Scrum Master on the cross-functional Agile team and serve in a leadership or consultant role for a therapeutic area or department.

Qualifications

• Bachelor's Degree in Analytic, technical, programming, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree. Required
• 7-9 years of progressive clinical database development experience (or master's degree with 6 years) and strong understanding of clinical research and clinical database development and Agile processes. Required
• 4-6 years Experience with database structures and programming languages. Preferred
• 4-6 years Experience with eCRF design and specifications development. Preferred
• 4-6 years Experience writing, programming, or configuring data validation checks. Preferred
• 4-6 years Experience with QC, UAT, platform testing, and writing and executing test scripts. Preferred
• 4-6 years Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and CDISC standards (CDASH, SDTM). Preferred
• 4-6 years Knowledge of software development lifecycle activities; experience with Agile/Scrum. Preferred
• Expertise in eCRF design, clinical database configuration, and system architecture. High
• Strong proficiency in SQL, programming, and implementation of data validation checks. High
• Deep understanding of CDISC standard, DASH, SDTM, and clinical research methodology. High
• Experience with Agile and Scrum processes and ability to serve as Product Owner or Scrum Master. High
• Strong analytical, problem solving, and technical troubleshooting skills. High
• Ability to mentor and provide technical leadership to team members. High
• Excellent communication and collaboration skills to work with cross functional teams. High

Requirements

• Designs and configures electronic case report forms (eCRFs), including metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations.
• Provides expertise in configuration of complex protocols, visit schedules/folders, and sites in relevant clinical data system builder or architect module.
• Performs complex eCRF and data system quality control, testing and verification activities with high degree of accuracy and consistency.
• Writes and executes test scripts for complex configurations.
• Implements/programs Data Validation Plans/Specifications; programs SQL based or configuration based data validation checks.
• Provides expertise for implementation of CDISC standards such as CDASH and SDTM within the EDC system.
• Implements complex Data Migration Plans (e.g., study data import/export, clone or transfer of previous study).
• Ensure compliance with industry quality standards, regulations, guidelines and procedures including applicable Federal Regulations and ICH/GCP.
• Utilizes tracking system to document configuration and testing activities, maintain version control on all required configuration specifications, validation, and quality control documents as required by SOP.
• May administer system modules (e.g., reports, PDF services, batch uploader) or perform user or site administration across applications.
• May serve as a Product Owner, Scrum Master, or Tester on the Agile team.
• Provides mentorship of senior team members and demonstrates technical leadership within a clinical data system or therapeutic area.
• Provides technical support to internal users for complex issues; reports defects and follows through to resolution.
• Performs other duties as assigned.
• Complies with all policies and standards.

Benefits

• Career advancement opportunities in a global health setting.
• Collaboration with passionate and purpose-driven professionals.
• Engagement in meaningful work that impacts healthcare.