Clinical Data Standards Specialist

4 days ago

Staten Island, New York, United States Katalyst Healthcares and Life Sciences Full time
Job Title: Clinical Data Manager III

Job Summary: We are seeking a highly skilled Clinical Data Manager III to join our team at Katalyst Healthcares and Life Sciences. The successful candidate will be responsible for ensuring compliance with clinical data standards and regulations, and will play a key role in the development and implementation of data standards policies and procedures.

Key Responsibilities:
  • Ensure compliance with CDISC guidance documents and implementation guides, as well as FDA guidance and regulation regarding electronic submission of data.
  • Develop and maintain a complete and in-depth understanding of CDASH and SDTM standards and concepts.
  • Design and review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards.
  • Develop and implement SDTM conformance mapping specifications and correct flaws proactively.
  • Collaborate with other functions to resolve identified issues and ensure any unresolved issues are appropriately documented.
  • Manage libraries of CDISC-related metadata, terminology, and related standards within the metadata repository.
  • Develop and implement data standards policies, procedures, and practices.
  • Communicate effectively with statistical programmers, statisticians, data scientists, clinical development, and regulatory teams.
  • Develop external reputation as a clinical data expert by actively participating in CDISC volunteer opportunities.
Requirements:
  • MS with 7 years of relevant clinical research experience or BS with 9 years of relevant clinical research experience.
  • Expert level of knowledge of at least two areas of clinical data standards, and high level of knowledge in at least one additional area.
  • Familiarity with other clinical data standards including BRIDG, ODM, and SHARE.
  • Experience in mapping and converting legacy data into SDTM domains for eCTD submissions.
  • Knowledge of international regulations, requirements, and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.

About Katalyst Healthcares and Life Sciences: We are a leading healthcare and life sciences company dedicated to delivering innovative solutions and services to our clients. Our team is passionate about making a difference in the lives of patients and communities around the world.

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