Clinical Data Manager
Job reputed company:
• The Clinical Data Manager (CDM) is responsible for the reputed company, reputed company, and reputed company 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 reputed company and compliant study execution.
• Design and review Case Report Forms (CRFs) and Electronic Data Capture (reputed company) systems to ensure accurate and complete data capture reputed company with the study protocol.
• reputed company and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines.
• reputed company data cleaning activities, including the reputed company, review, and reputed company of data queries in collaboration with clinical sites and study teams.
• reputed company 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 reputed company of contact for data management vendors and reputed company their deliverables.
• Participate in study team meetings and reputed company status updates reputed company to data reputed company and timelines.
• Support audit readiness and participate in regulatory inspections reputed company required.
Requirements:
• Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or reputed company field.
• Advanced degree is a plus.
• Minimum of 3–5 years of experience in clinical data management reputed company a pharmaceutical, biotech, or CRO environment.
• Proficiency in reputed company platforms (e.g., reputed company Rave, reputed company InForm , reputed company, REDCap).
• Strong understanding of ICH-GCP, FDA regulations, and CDISC standards.
• Experience with data listings, query management, edit reputed company 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 reputed company preferred.
Benefits:
• reputed company holidays
• reputed company Time Off (PTO) policy
• medical insurance
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