Lead Clinical Data Engineer - EDC/CDISC/FDA

Venesco,-LLC-; Frederick (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Venesco LLC is seeking a Clinical Database Developer to lead design, development, testing, validation, and maintenance of clinical trial databases for FDA-regulated programs. You will ensure compliance with FDA regulations, ICH guidelines, GCDMP and CDISC standards, while supporting data collection, quality control, and regulatory submissions.

The role focuses on EDC database work, CRF development, UAT, and collaboration with Trial Managers, Data Managers, SAS Programmers, and Biostatisticians

Qualifications

• Bachelor's degree as specified or equivalent in related field.
• Minimum 5 years of clinical database development experience.
• Experience with EDC systems and clinical trial databases.
• Knowledge of FDA-regulated clinical research and CDISC standards.
• Ability to obtain required DoD security credentials.
• CompTIA Security+ certification or ability to obtain within required timeframe.

Responsibilities

• Develop, configure, test, validate, implement, and maintain study-specific EDC databases.
• Create and maintain CDASH-annotated CRFs.
• Develop database specifications and validation documentation.
• Perform User Acceptance Testing (UAT) and system validation activities.
• Implement edit checks, derivations, and quality control procedures.
• Support database change management and version control processes.
• Generate data extracts, listings, and reports.
• Collaborate with Clinical Trial Managers, Data Managers, SAS Programmers, and Biostatisticians.
• Ensure compliance with FDA regulations, ICH E6, GCDMP, CDISC/CDASH, and SDTM standards.
• Support database lock activities and preparation of submission-ready datasets.

Skills

Regulatory compliance knowledge

DoD security credentials

Attention to detail

Education

Bachelor's degree in Computer Science, Information Systems, Health Informatics, Clinical Research, or related field

Tools

EDC systems

CDISC/CDASH standards

Job description

Venesco LLC is seeking a Clinical Database Developer to lead design, development, testing, validation, and maintenance of clinical trial databases for FDA-regulated programs. You will ensure compliance with FDA regulations, ICH guidelines, GCDMP and CDISC standards, while supporting data collection, quality control, and regulatory submissions.

The role focuses on EDC database work, CRF development, UAT, and collaboration with Trial Managers, Data Managers, SAS Programmers, and Biostatisticians