What are the responsibilities and job description for the Clinical Data Manager position at Katalyst CRO?
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.
- 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.