Clinical Data Manager

Katalyst Healthcares and Life Sciences

Austin, TX

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

Requirements:

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

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Vacancy posted 3 days ago

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