Lab Data Specialist - Central Services

ROLE SUMMARY

As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Senior Associate, Lab Data Specialist is responsible for managing local and central laboratory reference range information to support all Pfizer clinical trials with accurate and reliable safety lab data. The Senior Associate, Lab Data Specialist will be responsible for the timely and high quality development and delivery of reporting solutions supporting the Pfizer portfolio

ROLE RESPONSIBILITIES

• 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 Data Management 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.
• Supports the implementation of Clinical Data Interchange Standards Consortium (CDISC) Lab data standards and (LOINC)code
• 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.
• Ensure operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables.
• Supports knowledge development of data and study team members on safety lab data from local and central labs to support the accuracy and integrity of study data

BASIC QUALIFICATIONS

• BS degree in a life science discipline with a minimum of 3-5 years 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.)

PREFERRED QUALIFICATIONS

• Work experience in Hospital or clinical diagnostic laboratories

PHYSICAL/MENTAL REQUIREMENTS

Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc.

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