Clinical Data Manager Jobs in South Plainfield
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Search Results - Clinical Data Manager Jobs in South Plainfield
Katalyst Healthcares & Life Sciences-South Plainfield
compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
Contribute to the development and validation of data management software tools.
Requirements:
BSc or MSc in Life Sciences, Data/Computer Science...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.
Assist in creating external data transfer agreements, ensuring...
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Katalyst Healthcares & Life Sciences-South Plainfield
Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.
Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies...
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Katalyst Healthcares & Life Sciences-South Plainfield
programming in SAS.
6 years of experience with Clinical Data Management and clinical development technology solutions.
Understanding of the clinical trial processes, including common data standards (CDISC) and Study Data Tabulation Model (SDTM).
Ability...
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Katalyst Healthcares & Life Sciences-South Plainfield
SDTM data management.
Evaluate the current SDTM processes and solutions, and develop a roadmap for improvement and modernization
Design and architect new SDTM data flows, transformations, and integrations leveraging AWS services.
Assess the impact...
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Katalyst Healthcares & Life Sciences-South Plainfield
developer, database analyst/programmer, or clinical.
2+ years of experience programming in SQL and SAS.
Experience with CDISC SDTM mapping.
Experience with Clinical Data Management.
Experience with clinical development technology solutions...
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Katalyst Healthcares & Life Sciences-South Plainfield
Drug; and complete data base lock, archival, and closeout activities.
Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans...
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Katalyst Healthcares & Life Sciences-Iselin, 5 mi from South Plainfield
Responsibilities :
Serve as lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings.
Responsible for the study-specific data management tasks from protocol review to database lock to ensure data...
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Katalyst Healthcares & Life Sciences-Princeton (NJ), 20 mi from South Plainfield
or related area.
Must have 8 or more years of clinical data management experience in biotech / pharma industry with significant hands-on end-to-end experience in clinical data management practices.
Experience with clinical trials and the drug development...
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Katalyst Healthcares & Life Sciences-Staten Island, 12 mi from South Plainfield
with regard to data standards and functional operations. Train new Data Standards Analysts on process and systems related to the management and implementation of data standards.
CDISC involvement - Develops external reputation of a clinical data expert...
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