Overview
Principal Clinical Database DeveloperThe 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, and 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.
Responsibilities
- Designs and configures electronic case report forms (eCRFs), (e.g., metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations); consults with teams as expert in eCRF layout and clinical database design and has expertise in requirements writing; serves as department subject matter expert in design and configuration.
- Provides expertise in configuration of complex protocols, visit schedules/folders and sites in relevant clinical data system builder or architect module and advises on best approaches and implementation.
- Provides expertise in complex system/database build features both within EDC and any additional modules (e.g., ePRO, specimen tracking, randomization) as applicable to clinical data system; advises team to ensure streamlined system configuration and appropriate capability.
- Provides expertise in evaluating complex requirements, determines feasibility based on system capabilities, identifies and implements novel or unique solutions
- Performs complex eCRF and data system quality control, testing and verification activities with high degree of accuracy and consistency; may provide consultation to other teams within department
- Writes and executes test scripts for complex configurations.
- Performs EDC releases (Test, Train and Production), depending on the EDC system; including CRO global library.
- Implements/programs Data Validation Plans/Specifications; programs SQL based or configuration based data validation checks. Creates custom functions and procedures; reviews or performs manual data changes; may perform code review.
- Provides expertise for implementation of CDISC standards such as CDASH and SDTM within the EDC system; may perform SDTM mapping using SQL or other language; supports development and maintenance of global standards within therapeutic area.
- Implements complex Data Migration Plans (e.g., study data import/export, clone or transfer of previous study); configures or develops complex data integration, upload, or transfer.
- 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 contribute to review of department SOPs or work practices.
- 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; participates in Agile cross team coordination meetings to facilitate sharing of ideas and process improvements across teams.
- Provides mentorship of senior team members and demonstrates technical leadership within a clinical data system or therapeutic area; participates in initiatives or committees relevant to system delivery team processes.
- Provides technical support to internal users for complex issues; reports defects and follows through to resolution ensures proper escalation and notification to other impacted teams; may participate in review of system issue trends and corrective actions.
- Performs other duties as assigned
- Complies with all policies and standards
Qualifications
- Bachelor's Degree 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
If you're looking for a career where your work
advances global health and where
scientific excellence meets real-world impact, join us and be part of something bigger.
One Team, One Purpose.
