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Senior Associate, Senior Lab Data Specialist

2-8 years
Not Disclosed
10 May 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

During the study setup phase, ensure proper review of the protocol and laboratory Case Report Forms (CRFs). Configure the Lab Normal Management Tool accurately according to the protocol and CRFs. Create protocol-specific templates to capture missing lab parameters. Review lab slips and documents for Normal Reference Ranges and create new Lab IDs in the Electronic Data Capture (EDC) systems. Maintain Lab IDs and update normal reference ranges in the database, supporting both local and central lab IDs for all Pfizer studies.

Responsibilities

  1. Review protocol and lab CRFs during study setup phase.
  2. Configure Lab Normal Management Tool accurately.
  3. Create protocol-specific templates for capturing missing lab parameters.
  4. Review lab slips and documents for Normal Reference Ranges and create new Lab IDs in EDC systems.
  5. Maintain Lab IDs and update normal reference ranges in the database.
  6. Support both local and central lab IDs for all Pfizer studies.
  7. Create and maintain Lab Test Questions Library, Lab test units, and unit conversions into SI units.
  8. Handle Textbook Reference Ranges Requests and updates.
  9. Finalize Data Management by assigning lab codes to tests.
  10. Ensure proper mapping of vendor test codes to internal test codes.
  11. Develop, maintain, and update Lab-related SOP documents and guidelines.
  12. Support the implementation of CDISC Lab data standards and LOINC code.
  13. Serve as a technical Subject Matter Expert (SME) for lab data discrepancies.
  14. Support lab CRF design changes and User Acceptance Testing (UAT) for new safety lab data derivations and validations.
  15. Provide guidance to study teams on lab data collection and resolution of assignment issues.
  16. Serve as a technical SME for creating new Lab Data listings and reports.
  17. Test new/updated Lab Data listings and CTCAE grade reports.
  18. Review lab reconciliation reports and recommend actions to resolve lab data issues.
  19. Ensure operational excellence in collaboration with partners and colleagues.
  20. Drive process improvements and lead organizational initiatives.
  21. Measure and publish lab ID creation cycle time and productivity metrics.

Work Location Assignment

Flexible

Why Pfizer?

Pfizer offers unique career opportunities in a culture of individual ownership. They believe in improving future healthcare and transforming lives globally. Join Pfizer's global community to contribute to innovative therapies that promote a healthier world.