Senior Digital Clinical Data Manager

Cambridge, MA, United States

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Biogen

Biogen is a leading global biotechnology company that pioneers science and drives innovations for complex and devastating diseases. Biogen is advancing a pipeline of potential therapies across neurology, neuropsychiatry, specialized immunology...

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Job Description

At Biogen Digital Health (BDH), we aspire to transform Biogen and patients’ lives by making personalized & digital medicine in neuroscience a reality. Powered by data-science and digital technologies, we drive solutions to advance research, clinical care, and patient empowerment. Our team strives for real impact through excellence, innovation, and collaboration. As Senior Digital Clinical Data Manager reporting to Head, BDH Data as a Product, you will be responsible for:
 

  • Designing, validating, and maintaining uptime for data capture systems and clinical databases from study design to database lock
    • Consult with teams within data office and across studies to solve operational or data problems, including data review and reconciliation

    • Ensure consistency, integrity, security, and accuracy of data based on project specific guidelines

    • Develop and file clinical data management documentation

    • Query data inconsistencies and provide root cause analysis / remedies in compliance with standard operating procedures

    • Escalate key situations as appropriate

  • Developing and governing data management plans for key BDH studies (both BDH sponsored and when matrixed into WM/R&D)
    • Work “two in a box” with clinical operations team on data availability in BDH Data Platform

    • Work with platform team to support scientific data product needs through parameterization, cleaning, auditing, and data cuts

  • Designing and producing key data products for study management, clinical operations, and science
    • Prepare reports, interim data, statistical comparisons, data charts, and other scientific support products

    • Develop and maintain dashboards for study managers

    • Assist clinical operations team with data including joining as member of SMT/study meetings as needed

    • Build and parameterize extract, transform, and load (ETL) processes leveraging Python, SQL, and Spark to generate high-integrity data products

  • Partnering with clinical operations and data platform to manage clinical studies through parameterization, cleaning, auditing, and data cuts
    • Join clinical studies at launch phase as SME accountable for data management planning

    • Write and gain consensus around DMPs (including Data Review Plans and related documentation such as eCRF guidance and data transfer specifications) on a per-study basis

    • Support execution against DMPs at study close, interim analysis, or other relevant time points  

This role is of key importance to achieve the strategic vision and objective to make Biogen a recognized leader in digital health sciences, hence contributing to our corporate vision & strategy.  

Qualifications

 

  • B.A. or B.Sc. in a scientific discipline; advanced degree preferred.
  • Approximately 5-8 years of clinical data management
  • Strong knowledge of key standards (i.e. Hl7, FHIR, CDISC)
  • Experienced in clinical studies across all phases of development, including SaMD
  • Experienced with EDC systems
  • Experience working within cross functional digitally enabled research
  • Scientifically astute with a high degree of learning agility
  • Prior digital health or learning health system experience
  • Deep experience in GCP/GxP systems
  • Deep knowledge of digital & data

Additional Information

At Biogen Digital Health (BDH), we aspire to transform Biogen and patients’ lives by making personalized & digital medicine in neuroscience a reality. Powered by data-science and digital technologies, we drive solutions to advance research, clinical care, and patient empowerment. Our team strives for real impact through excellence, innovation, and collaboration.

Tags: Data management ETL GCP Python R R&D Research Security Spark SQL Statistics

Region: North America
Country: United States
Job stats:  5  0  0
Category: Leadership Jobs

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