Clinical Data Manager
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 Now
Apply Now
• 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 Now
Apply Now