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    Clinical Data Manager - South San Francisco, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences South San Francisco, United States

    3 weeks ago

    Default job background
    Description
    Responsibilities:
  • Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies.
  • Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing.
  • Monitor data collection, coding, and cleaning by vendors through tracking of study metrics, internal data reviews and vendor key performance indicators.
  • Oversight of database lock activities and ultimate archiving of study data
  • Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors.
  • Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members.
  • Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation.
  • Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution.
  • Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations.

    • Requirements:

  • BS/BA in scientific discipline
  • At least years of clinical data management experience in a pharmaceutical/biologics/biotechnology company
  • Experience working in clinical drug development through Phase in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred.
  • Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
  • Experience leading initiatives/projects for SOP, process and standards development within clinical data management.
  • Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation.
  • Experience working with Medidata Rave
  • Experience using standardized medical terminology, including MedDRA and WHODrug
  • Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
  • Excellent written and oral communications skills
  • Highly motivated and flexible, with excellent organizational, time and project management skills
  • Ability to work independently and as part of a multi-disciplinary team.
  • Understanding of ICH GCP as well as general knowledge of industry practices and standards
  • Knowledge and understanding of regulatory requirements and expectations for clinical data systems including CFR Part
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