Clinical Database Developer
About this role
Description
Clinical Database Developer
Venesco LLC is seeking a Clinical Database Developer to serve as the technical lead for the design, development, testing, validation, implementation, and maintenance of clinical trial databases supporting FDA-regulated medical product development programs. The individual ensures clinical databases meet FDA regulatory requirements, ICH guidelines, Good Clinical Data Management Practices (GCDMP), and CDISC standards, while supporting data collection, quality control, and regulatory submissions.
Requirements
Duties and Responsibilities
- Develop, configure, test, validate, implement, and maintain study-specific electronic data capture (EDC) databases.
- Create and maintain CDASH-annotated Case Report Forms (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.
Minimum Qualifications
- Bachelor's degree in Computer Science, Information Systems, Health Informatics, Clinical Research, or 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.
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
For more information on Venesco, LLC., visit https://venesco.com.
Company at a glance
Venesco, LLC is a premier government contractor delivering Healthcare, IT, Research & Development, and a range of mission‑critical services to federal agencies. For more than 18 years, we’ve evolved from a small consulting firm into a respected leader in biomedical R&D and IT support, backed by strong financials, mature processes, and a commitment to employee connectedness and work–life balance.
Our success is driven by our skilled professionals, agile management practices, and high‑quality standards. Venesco holds a Top‑Secret Facility Clearance and maintains CMMI® Maturity Level 3 (Services) and ISO 9001:2015 and 14001:2015 certifications. We’ve been recognized on the Inc. 5000 and Washington Technology’s Fast 50 lists for five consecutive years.
With more than 350 credentialed employees and 65+ prime contracts — ranging from small teams to programs with 150+ personnel — we deliver the impact of a large enterprise while maintaining the agility of a small business. Venesco continues to recruit motivated, talented individuals who want to contribute to meaningful federal initiatives and join a collaborative, high‑performing team.
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