Clinical Data Manager
Clinical Data Manager
Posted on :
30-04-2025
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1 Vacancy
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Job Description
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 protocolspecific requirements.
- This role collaborates closely with crossfunctional teams including Clinical Operations Biostatistics Medical Writing and Regulatory Affairs to support timely and compliant study .
- 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 ICHGCP).
- 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.
- 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 ICHGCP 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 problemsolving skills.
- Strong communication and collaboration skills across crossfunctional teams.
Employment Type
Full Time
Key Skills
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