Clinical Data Manager
Clinical Data Manager
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Salary Not Disclosed
1 Vacancy
Job 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.
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.
- Bachelors 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 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.
Employment Type
Full-time
