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    • Senior Clinical Data Manager - San Jose - Katalyst HealthCares and Life Sciences

    Katalyst HealthCares and Life Sciences
    Katalyst HealthCares and Life Sciences San Jose

    2 days ago

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    Description

    Job Description

    We are seeking a highly experienced Clinical Data Manager to support our team in the management of clinical studies.

    Key Responsibilities

    • Support the Lead Data Manager across one or more clinical studies, reviewing protocols for appropriate data capture and electronic case report form (eCRF) design.
    • Provide expertise and support in the oversight of database set-up/migrations/upgrades, including coordinating and/or performing User Acceptance Testing.
    • Review and generate study documents, such as the Data Management Plan, CRF Completion Guidelines, and DB build specifications.
    • Conduct oversight of data management vendors via ongoing review of quality and performance metrics.
    • Lead the Data Review plan check, specification and validation updates.
    • Facilitate and participate in scheduled and ad hoc data listing review.
    • Generate, resolve, and track data queries to ensure the integrity of the clinical data.
    • Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
    • Review and provide feedback to the clinical team on other study documents.

    Requirements

    • Minimum BA/BS in scientific or health-related field.
    • Minimum of 9-11 years of clinical data management experience in the pharmaceutical and biotechnology industry or in a Contract Research Organization (CRO).
    • At least 1 year experience working at a Sponsor.
    • Oncology trial experience required, hematology/oncology preferred.
    • Comprehensive understanding of regulatory guidelines and industry standards.
    • Proficient with Medidata RAVE and experience with Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
    • Familiarity with various data visualization, analytics, and reporting tools is a plus.

    Skills and Abilities

    • Excellent communication skills (verbal and writing).
    • Ability to multi-task and take on new responsibilities as needed in a fast-paced setting.
    • Strong organizational skills and ability to prioritize tasks.
    • Proven ability to work independently and in a team setting.
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Senior clinical data manager