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Clinical Programmer, Clinical Data Management

Company: SQRL
Location: New York
Posted on: June 25, 2022

Job Description:

Highlights:

  • Hybrid schedule with a great office location in Manhattan!
  • Work on the cutting edge of research for CNS Disorders
  • Huge company growth! Valuation went from $100 million to $2 Billion in just a year!
  • Smaller company = amazing team and great entrepreneurial culture**This is a hybrid role with two remote days and three on site days in Manhattan!The Company: Our Manhattan based client is a clinical-stage biopharmaceutical company that develops solutions for CNS disorders. They are on the cutting edge of research and have gone through a ton of growth through positive data from their clinical trials. 2 out of 6 drugs in their pipeline received FDA Breakthrough therapy status, they filed 2 NDA's in 2021 with a 3rd NDA filing coming shortly. They've built one of the most incredible leadership teams - a diverse group of leaders and entrepreneurs!The Role: You will be responsible for supporting data management activities in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. This role supports clinical trial managers, clinical research associates, and Medical Monitors in all technical data management related activities across multiple programs.
    • Generate data listings and patient profiles to support data management and other functions in review of clinical data
    • Assists in external vendor reconciliation
    • Supports the development of data transfer agreements/specifications with external vendors
    • Reviews and maintains data migrations or integrations
    • Supports QC work of statistical/programming deliverables
    • Serves as liaison with technical statistics/programming vendors
    • Ensures appropriate documentation and QC of deliverables
    • Participates and provides input in electronic Case Report Forms (eCRFs) and edit check specifications development
    • Creates statistical/programmatic outputs to be used in final reports, publications, posters, manuscripts, etc.
    • Gathers metrics to support risk-based monitoringQualifications:
      • Bachelor's degree in statistics, life sciences or IT related degree
      • 2+ years experience in SAS programming at a biotech/pharma or CRO
      • Good understanding of FDA, GCP and ICH guidelines
      • Experience with electronic data capture systems/technologies as applied to clinical trials
      • Strong working knowledge of CDISC standards, including SDTM and ADaM
      • Good working knowledge of (e)CRF design and clinical data

Keywords: SQRL, New York , Clinical Programmer, Clinical Data Management, IT / Software / Systems , New York, New York

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