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Senior CDM

Senior Data Manager

Position Summary

The Data Manager will support the Director of Data Management in all data management activities.

Essential Duties and Responsibilities

  • Participate in the review of Clinical Research documents (eg. Protocols, Case Report Forms, Reports and Statistical Analysis Plan).
  • Work with Data ManagementCRO on the following
    • Develop Case Report Form (CRF), electronic and/or paper
    • Develop Interactive Web-based Randomization System (IWRS)
    • Develop database (DB) clinical trial data specifications, user requirements, edit rules/checks, query logic and data validations
    • Coordination of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report
    • Reconciliation of electronic data transfers from vendor to Sponsor
  • Coordinate/perform User Acceptance Testing (UAT) on EDC and IWRS
  • Perform training on study trial for EDC, IWRS and create user guides
  • Implement data cleaning plan and assist in data review, including the freezing and unfreezing of patient data within the EDC
  • Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
  • Assist in reconciling AE/SAE data in Safety DB and/or Data Management DB
  • Coordinate coded data review/approvals using MedDRA and WHO-DD
  • Participate in the preparation and presentation of data, when applicable
  • Oversee all deliverables required for timely DB Lock
  • Ensures data system compliance by following the established guidelines of national and international regulatory authorities
  • Participate in conference calls and/or meetings with vendors and project team meetings

Education /Experience Required

  • Bachelor's degree in scientific discipline or related field required
  • Minimum of 5-7 years of Data Management experience to include essential duties above within a pharmaceutical, biotech or related environment required
  • Working knowledge of Good Clinical Practices, Clinical Research, Gene Therapies, Clinical trial process and related regulatory requirements and terminology
  • Working knowledge of Clinical database applications such as EDC, IWRS and CTMS

Other Skills and Abilities

  • Applicable knowledge working with Medidata RAVE, Inform EDC, OC RDC, Oracle Clinical, SAS,
  • Experience with working on Phase I-IV study trials within the pharmaceutical and /or biotechnology industry

Sthree US is acting as an Employment Business in relation to this vacancy.