Principal Clinical Database Developer

Emmes Group•Rockville, MD

About The Position

The Principal Clinical Database Developer (PCDD) is an expert in delivering high-quality electronic data capture (EDC) platform and clinical database study configurations. Working as an integral part of an agile team, the PCDD serves as a lead consultant on EDC user acceptance testing (UAT), data integration, upload or transfer development, and global library and standards development. The role requires proficiency in creating SQL-based or configuration-based data validation checks and expertise in implementing CDISC standards such as CDASH and SDTM within EDC systems. The PCDD is a technical subject matter expert on clinical database development and may serve as a Product Owner or Scrum Master on a cross-functional Agile team, as well as a leader or consultant for a therapeutic area or department. The position designs and configures eCRFs and complex clinical database builds, evaluates requirements and system capabilities, implements testing and quality control, and supports data validation, migration, integration, and standards. It also includes technical support, mentoring, and leadership responsibilities, while ensuring compliance with applicable quality standards, regulations, guidelines, and procedures.

Requirements

Bachelor's degree in an analytic, technical, programming, or related discipline; an equivalent combination of education and relevant work experience may be considered in lieu of a degree.
7–9 years of progressive clinical database development experience, or 6 years with a master's degree, with a strong understanding of clinical research, clinical database development, and Agile processes.
Expertise in eCRF design, clinical database configuration, and system architecture.
Strong proficiency in SQL, programming, and implementing data validation checks.
Deep understanding of CDISC standards, including CDASH and SDTM, and clinical research methodology.
Experience with Agile and Scrum processes and ability to serve as a Product Owner or Scrum Master.
Strong analytical, problem-solving, and technical troubleshooting skills.
Ability to mentor and provide technical leadership to team members.
Excellent communication and collaboration skills for working with cross-functional teams.

Nice To Haves

4–6 years of experience with database structures and programming languages.
4–6 years of experience with eCRF design and specification development.
4–6 years of experience writing, programming, or configuring data validation checks.
4–6 years of experience with QC, UAT, platform testing, and writing and executing test scripts.
4–6 years of knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and CDISC standards (CDASH, SDTM).
4–6 years of knowledge of software development lifecycle activities and experience with Agile/Scrum.

Responsibilities

Design and configure eCRFs, including metadata, eCRF libraries, data checks, derivations, skip logic, rules, alerts, and calculations; consult on eCRF layout, database design, and requirements writing.
Configure complex protocols, visit schedules or folders, and sites in relevant clinical data system builder or architect modules, and advise on implementation approaches.
Provide expertise in complex EDC and additional clinical data system modules, such as ePRO, specimen tracking, and randomization, to support streamlined configurations.
Evaluate complex requirements, determine feasibility based on system capabilities, and identify and implement novel or unique solutions.
Perform complex eCRF and data system quality control, testing, and verification; provide consultation to other department teams as needed.
Write and execute test scripts for complex configurations.
Perform EDC releases for Test, Train, and Production environments, as applicable, including CRO global library releases.
Implement and program Data Validation Plans and Specifications, including SQL-based or configuration-based checks; create custom functions and procedures, review or perform manual data changes, and potentially perform code review.
Support implementation of CDISC standards such as CDASH and SDTM within EDC systems; potentially perform SDTM mapping using SQL or another language and support therapeutic-area global standards.
Implement complex data migration plans, including study data import, export, cloning, or transfer; configure or develop complex data integration, upload, or transfer processes.
Ensure compliance with industry quality standards, regulations, guidelines, and procedures, including applicable Federal Regulations and ICH/GCP.
Use tracking systems to document configuration and testing, maintain version control for required specifications and validation and quality-control documents, and potentially contribute to SOP or work-practice reviews.
Potentially administer system modules, such as reports, PDF services, or batch uploader, and perform user or site administration across applications.
Potentially serve as Product Owner, Scrum Master, or Tester on an Agile team and participate in cross-team coordination meetings to share ideas and improve processes.
Mentor senior team members, demonstrate technical leadership within a clinical data system or therapeutic area, and participate in initiatives or committees relevant to system delivery processes.
Provide technical support to internal users on complex issues, report defects, follow through to resolution, ensure appropriate escalation and notification, and potentially participate in system-issue trend and corrective-action reviews.
Perform other duties as assigned.
Comply with all policies and standards.