Clinical Data Manager
RemoteUnited States
Job Summary
Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate data capture aligned with study protocols. Develop data management plans, validation specifications, and CRF completion guidelines while overseeing data cleaning activities and query resolution with clinical sites. Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations, ensuring adherence to CDISC, SDTM, FDA, and ICH-GCP standards. Manage database lock activities, prepare clinical study reports, and serve as the primary contact for data management vendors. Participate in study team meetings, support audit readiness, and conduct regulatory inspections as required. This remote role requires a Bachelor's degree in Life Sciences or related fields with 3–5 years of clinical data management experience and proficiency in EDC platforms like Medidata Rave or Oracle InForm.
Required Qualifications
- Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field
- Minimum of 3–5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment
- Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap)
- Strong understanding of ICH-GCP, FDA regulations, and CDISC standards
- Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug)
- Excellent organizational, analytical, and problem-solving skills
- Strong communication and collaboration skills across cross-functional teams
- Experience working on global, multi-site clinical trials
Desired Qualifications
- Advanced degree
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