Job Description:
The Clinical Data Manager Engineer in AI Ahmadi is responsible for overseeing the collection, cleaning, and validation of clinical trial data. The role combines technical expertise in database design and data pipelines with knowledge of clinical trial methodologies and regulatory requirements. Key responsibilities include developing data management plans, designing CRFs (case report forms), configuring EDC (electronic data capture) systems, and ensuring timely data delivery to statisticians and regulatory teams. The engineer ensures data integrity, collaborates on clinical protocol development, and supports audit readiness for regulatory agencies.
Job Requirement:
A degree in computer science, biomedical engineering, or health informatics is required. At least 4 years of experience in clinical data management or clinical informatics is essential. Knowledge of clinical trial data standards such as CDASH, SDTM, and MedDRA is important. Experience with tools such as Medidata Rave, Oracle Clinical, or OpenClinica is necessary. Proficiency in SQL, Python, or SAS is beneficial for custom report generation and data integration tasks. Candidates must be detail-oriented, familiar with ICH-GCP and FDA CFR Part 11 regulations, and capable of working under tight deadlines with cross-functional teams.
