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Katalyst HealthCares & Life Sciences
Clinical Data managerKatalyst HealthCares & Life Sciences • San Francisco, CA, CA
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Clinical Data manager

Clinical Data manager

Katalyst HealthCares & Life Sciences • San Francisco, CA, CA
30+ days ago
Job type
  • Full-time
Job description


Responsibilities:

  • Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close
  • This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks
  • They will ensure optimized data collection, flow and access across EDC and non-EDC data sources
  • They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases
  • The role will operate as a key member of the Clinical Operations team
  • Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements
  • Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection
  • Perform data entry and cleaning activities, including discrepancy management and query resolution
  • Conduct data validation checks and implement quality control measures to ensure accuracy and completeness
  • Collaborate with study team members to resolve data-related issues and discrepancies
  • Generate and review data listings, summaries and reports for data review
  • Serve as a primary or backup resource for issues about data management
  • Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations
  • Contribute to the development and validation of data management software

Requirements:

  • BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience
  • - years of data management experience in the pharmaceutical or biotechnology industries
  • Strong expertise in project/program management including stakeholder management
  • Knowledge of industry standards (CDISC, SDTM, CDASH)
  • In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, CFR Part
  • Proven ability to preemptively identify data and system issues and mitigate risks to data quality
  • Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data
  • Experience in development and implementation of Clinical data management standards and procedures
  • Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug

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Clinical Data manager • San Francisco, CA, CA

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