Principal Clinical Data Manager Job at Cytel - EMEA, Cambridge, MA

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  • Cytel - EMEA
  • Cambridge, MA

Job Description

JOB DESCRIPTION

JOB RESPONSIBILITIES:

  • Adherence to SOPs and maintaining audit-ready documentation.
  • Coordinate and oversee activities of all DM staff assigned to the project, ensuring

    high quality, respecting project timelines and adherence to the budget.
  • Attend relevant project meetings and work closely with other internal and external

    leads.
  • Liaise with client/partners for clarification on any clinical and / or technical decisions

    and propose most efficient solutions.
  • Identify risks to project deliverables and timelines, develop and implement the

    mitigations for these risks.
  • Create DM timelines for database set-up.
  • Lead and participate in the design of Clinical Electronic Data Capture (EDC)

    components including mock CRF, casebook, edit checks.
  • Coordinate and create data management documentation including Data Management
  • Plan, Data Validations Specifications, eCRF Completion Guidelines, Data Collection

    System Configuration, Data Transfer Agreement.
  • Coordinate and perform User Acceptance Testing.
  • Train EDC users.
  • Manage EDC users’ access and assist with resolving issues.
  • Coordinate all conduct Data Management tasks.
  • Lead and participate in data cleaning activities including SAE and external data

    reconciliation.
  • Provide input to protocol and assess database impacts based on protocol changes

    during study lifecycle; prepare and execute change request forms.
  • Lead and participate in Database Lock activities, including timelines creation, QC

    coordination and Data Management Report creation.
  • Contribute to departmental procedures and guidelines.
  • Critically evaluate data management needs and propose appropriate, innovative, and

    efficient data management solutions.
  • Train and mentor less experienced staff.
  • Represent Cytel at project, proposal, or industry meetings.
  • May participate in the recruitment process.
  • Contribute to budget evaluation for proposal writing purpose and be Data

    Management representative during bid-defense, as needed.
  • Support senior team members and/ or be the data management representative

    during audits.
  • May act as a line manager, contribute to the development of a strong team of data

    managers, by functionally managing and guiding the data managers with respect to data management strategy, deliverables, processes, and professional development.

Job Tags

Permanent employment,

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Job Summary
  • Location
    Cambridge, MA
  • Job Type
    Full Time
  • Date Posted
    2025-01-18
  • Expiration date
    2025-02-17