Clinical Data Manager
Job Description: • The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. • The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements. • This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution. • Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol. • Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines. • Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams. • Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations. • Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP). • Manage database lock activities and contribute to the preparation of clinical study reports (CSRs). • Serve as the primary point of contact for data management vendors and oversee their deliverables. • Participate in study team meetings and provide status updates related to data quality and timelines. • Support audit readiness and participate in regulatory inspections when required. Requirements: • Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field. • Advanced degree is a plus. • 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 preferred. Benefits: • paid holidays • Paid Time Off (PTO) policy • medical insurance Apply tot his job