Associate Clinical Database Developer
About the job
The Emmes Company, LLC (“Emmes”) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients’ success by sharing ideas openly and honestly.
The Associate Clinical Database Developer (ACDD) is responsible for assisting with delivering highquality electronic data capture (EDC) platform and clinical database study configurations. ACDDs work as an integral part of an agile team performing data system configuration, quality control, testing, and may also provide support for activities such as user acceptance testing (UAT) of EDC systems, creation of SQL-based or configuration-based data validation checks, and/or implement CDISC standards such as CDASH and SDTM within the EDC system.
- Assists with design and configuration of electronic case report forms (eCRFs), (e.g. metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations)
- Assists with configuring protocol, visit schedules/folders and sites in relevant clinical data system builder or architect module
- Assists with configuration of system/database build features both within EDC and any additional modules (e.g., ePRO, specimen tracking, randomization) as applicable to clinical data system
- Assists in evaluation of requirements and determining feasibility based on system capabilities
- Performs eCRF and data system quality control, testing and verification activities
- Assists with adapting and executing test scripts for routine configurations
- May perform EDC releases (Test, Train and Production), depending on the EDC system
- Supports implementation of Data Validation Plans/Specifications; may support creation of SQL-based or configuration-based data validation checks
- Assists with implementation of CDISC standards such as CDASH and SDTM within the EDC system
- Supports implementation of 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
- Actively participates as an Agile team member in all meetings
- Provides technical support to internal users, reports defects
- Other duties as assigned
- Bachelor’s degree in an analytic, technical, programming, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree
- Experience with database structures and programming languages a plus
- Experience with eCRF design and specifications development a plus
- Experience writing, programming, or configuring data validation checks preferred
- Experience with QC, UAT, platform testing, and writing and executing test scripts preferred
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and CDISC standards (CDASH, SDTM) preferred
- Knowledge of software development lifecycle activities; experience with Agile/Scrum a plus
- Strong computer skills; experience with eCRF design, clinical databases, EDC systems or other web-based data collection systems
- Excellent oral and written communication skills
- Skills in prioritization, organization, and time management
- Team player