Clinical Data Manager
Seattle, WAContractor
Behavioral Health Market Context
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Job Description
nd Regulatory Affairs, to support timely and compliant study execution.
Responsibilities
• 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 35 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, WHO Drug).
• 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.
Responsibilities
• 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 35 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, WHO Drug).
• 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.
Qualifications
- •Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field
- •Minimum of 35 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, WHO Drug)
- •Excellent organizational, analytical, and problem-solving skills
- •Strong communication and collaboration skills across cross-functional teams
Benefits
Responsibilities
- •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
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