• Review Lab slips, documents for Normal Reference Ranges for all protocol required lab tests to create new Lab (Identifiers) IDs in EDC systems.
• Maintenance of Lab IDs and updates in normal reference ranges in database.
• Support both Local and Central lab IDs for all Pfizer studies.
• Textbook Reference Ranges Requests and updates.
• Assist in assigning lab codes to tests for lab data that are coming in house either on the CRF or by electronic transfer.
• Comply with all Lab related SOP documents and guidelines.
• Provides guidance to the study management for collection of complete and accurate Reference range documents from Investigator sites.
• Provides guidance to the study team for assignment of Lab IDs all study lab data, analysis, and resolution of assignment issues.
• Support data managers in review and possible remediation of lab data discrepancies in study conduct and reporting.
• Run Lab Data listings and reports from Pfizer browser tools and applications.

Support team members with their process improvement and automation initiatives

Qualifications

Basic Qualifications

• Bachelor’s degree in a life science discipline with 0-1 year of relevant experience in a pharmaceutical, biotech, CRO, or Regulator Agency with an emphasis on safety lab data solutions.
• Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.)
• CDISC knowledge and experience are preferable
• Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills
• Experience in clinical data management and EDC systems such as Oracle Clinical, Data Labs, Rave and InForm.
• Good understanding of laboratory data collection (laboratory tests and their collected units)
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Additional Preferred Qualifications

• Knowledge and/or Experience using relational databases (e.g., Oracle) and data visualization and reporting tools (e.g., Spotfire, J Review)

• Work experience in Hospital or clinical diagnostic laboratories

Work Location Assignment: Flexible
 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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