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Mid-level remote data role at a well-known employer in a metro market, increasing applicant competition.
Strong clinical trial regulatory requirements (ICH-GCP/21 CFR 11) limit cross-industry transferability, increasing background sensitivity.
Mandatory 5–10 years plus SAS/SQL/Python and clinical regulatory experience enforces strict shortlisting.
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Plan, design, and maintain clinical databases including programming, testing, and documentation following standards and validation procedures.
Manage data acquisition activities such as vendor specification creation, data transfer, handling blinded data, and quality assessments within clinical systems.
Develop and update programs/reports on report management systems, coordinate timelines and deliverables, and may serve as Lead Programmer coordinating with internal and external teams.
5 to 10 years of work experience in related roles.
Bachelor's degree in Computer Science, Life Sciences, or a related field; equivalent education and experience may be considered.
Proficiency in SAS, SQL, and Python; working knowledge of relational databases and electronic data capture technologies.
Knowledge of relevant regulations including ICH-GCP and 21 CFR Part 11; ability to handle blinded data and quality assessments.
Experienced in clinical data management systems with a strong technical programming background in SAS/SQL/Python.
Capable of managing complex data acquisition workflows and coordinating with multiple stakeholders in clinical research environments.
Familiar with regulatory compliance requirements and validation procedures for clinical database systems.