Senior Associate, Senior Lab Data Specialist

ROLE RESPONSIBILITIES

• Review protocol and lab CRFs during study set up phase. Ensure Lab Normal Management Tool is configurated accurate as per protocol and lab CRFs
• Create protocol specific template for each study to capture missing lab parameters.
• 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.
• Create and Maintain of Lab Test Questions Library, Lab test units and its conversions into SI units, Unit Conversion formulas and preferred copy groups.
• Textbook Reference Ranges Requests and updates.
• Finalize Data Management assigning lab codes to tests for lab data that are coming in house either on the CRF or by electronic transfer.
• Work closely with Data Acquisition to ensure proper mapping of vendor test codes to our test codes.
• Develop, Maintain and update all Lab related SOP documents and guidelines.
• Supports the implementation of Clinical Data Interchange Standards Consortium (CDISC) Lab data standards and (LOINC) code.
• Serves on the data standards board as needed, and leads as needed implementation and where needed development of safety lab data standards.
• Supports lab CRF design changes, test and User Acceptance Testing (UAT) new safety lab data derivations and validations.
• 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.
• Serve as a technical Subject Matter Expert (SME) to the study teams and data managers for analysis and remediation of lab data discrepancies in study conduct and reporting.
• Serve as a technical SME for creation of new Lab Data listings and reports from Pfizer browser tools and applications.
• Responsible for testing of new / updated Lab Data listings and CTCAE grade report.
• Review lab reconciliation report and recommend data managers on the potential action to resolve lab data issue
• 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.
• Directly 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
• Drive process improvements and lead organizational initiatives.
• Measure and publish lab ID creation cycle time and productivity metrics.

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 system

·       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.)

·       Work experience in Hospital or clinical diagnostic laboratories preferable

·       Experience using relational databases (e.g., Oracle) and data visualization and reporting tools (e.g., Spotfire, J Review).

PHYSICAL/MENTAL REQUIREMENTS

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to travel ~5%.

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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