Clinical Database Developer

The Emmes Corporation - Rockville, MD

Full-time - Senior

Remote - Rockville, MD

Professional, Scientific, and Technical Services

About the position

The Clinical Database Developer at Emmes Corporation is responsible for delivering high-quality electronic data capture (EDC) platform and clinical database study configurations. This role involves working as part of an agile team, leading user acceptance testing (UAT) of EDC systems, and providing expertise in data integration and validation checks. The position requires a strong understanding of clinical research and database development, with a focus on implementing CDISC standards and ensuring compliance with industry regulations.

Responsibilities

• Designs and configures electronic case report forms (eCRFs) including metadata, data checks, and calculations.
• Consults with teams as an expert in eCRF layout and clinical database design.
• Provides expertise in configuration of complex protocols and advises on best approaches.
• Evaluates complex requirements and implements novel solutions.
• Performs quality control, testing, and verification activities for eCRFs and data systems.
• Writes and executes test scripts for complex configurations.
• Implements Data Validation Plans and programs SQL-based data validation checks.
• Creates custom functions and procedures and performs code reviews.
• Implements CDISC standards such as CDASH and SDTM within the EDC system.
• Administers system modules and performs user administration across applications.
• Mentors senior team members and demonstrates technical leadership.
• Provides technical support to internal users for complex issues.

Requirements

• Bachelor's degree in an analytic, technical, programming, or related discipline.
• At least 8 years of progressive clinical database development experience (or master's degree with 6 years).
• Strong understanding of clinical research and clinical database development.
• Experience with database structures and programming languages.
• Experience with eCRF design and specifications development.
• Experience writing, programming, or configuring data validation checks.
• Knowledge of ICH/GCP guidelines and CDISC standards.

Nice-to-haves

• Experience with QC, UAT, platform testing, and writing and executing test scripts.
• Strong computer skills with experience in EDC systems like Medidata Rave or Oracle Clinical.
• Excellent oral and written communication skills.
• Skills in prioritization, organization, and time management.

Benefits

• Health insurance
• 401(k)
• Tuition reimbursement
• Work from home
• Parental leave