Job Description
Key Responsibilities:
- Review lab slips and documents to establish Normal Reference Ranges for all protocol-required lab tests and create new Lab IDs in EDC systems.
- Maintain Lab IDs and update normal reference ranges in the database.
- Support both local and central lab IDs for all Pfizer studies.
- Handle textbook reference ranges requests and updates.
- Assist in assigning lab codes to tests for lab data collected in-house, either on the CRF or via electronic transfer.
- Ensure compliance with all Lab-related SOP documents and guidelines.
- Provide guidance to study management teams for collecting complete and accurate reference range documents from investigator sites.
- Guide study teams in assigning Lab IDs for study lab data, analysis, and resolving assignment issues.
- Support data managers in reviewing and remediating lab data discrepancies during study conduct and reporting.
- Run lab data listings and reports using Pfizer browser tools and applications.
- Support team members with process improvement and automation initiatives.
Qualifications:
Basic Qualifications:
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- Bachelor’s degree in a life science discipline.
- 0-1 year of relevant experience in a pharmaceutical, biotech, CRO, or regulatory agency with a focus on safety lab data solutions.
- Understanding of the drug development process and data operations required for clinical trial data reporting (e.g., data review, study reports, regulatory submissions, safety updates, etc.).
- Knowledge of CDISC standards is preferable.
- Strong communication, decision-making, influencing, negotiation, and project management skills.
- Experience in clinical data management and EDC systems like Oracle Clinical, Data Labs, Rave, and InForm.
- Good understanding of laboratory data collection, including laboratory tests and their collected units.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, etc.).