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.
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.
