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The Role
Manages safety laboratory data for clinical studies, including lab ID creation, reference ranges, test units, coding, data mapping, standards, reconciliation, reporting, validation, and discrepancy remediation. Partners with data management and study teams, supports CDISC and LOINC implementation, maintains lab procedures, provides technical subject matter expertise, develops data-cleaning reports, supports UAT, and leads process improvements and productivity metrics.
Summary Generated by Built In
ROLE RESPONSIBILITIES
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
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical
- 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%.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical
Skills Required
- Bachelor's degree in a life science discipline
- 3-5 years of relevant experience in pharmaceutical, biotech, CRO, or regulatory agency settings, emphasizing safety lab data solutions
- Understanding of the drug development process and clinical trial data operations
- Experience in clinical data management and EDC systems
- Understanding of laboratory data collection, including laboratory tests and collected units
- Proficiency with Microsoft Office Suite, including Outlook, Word, and Excel
- Strong written and oral communication, decision-making, influencing, negotiation, and project management skills
- CDISC knowledge and experience
- Work experience in a hospital or clinical diagnostic laboratory
- Experience with relational databases such as Oracle
- Experience with data visualization and reporting tools such as Spotfire and J Review
What the Team is Saying
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Diagnostics Launch Lead
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Pfizer
Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Healthcare coverage is described as comprehensive, with multiple plan options, dental and vision, mental-health services, telehealth, and eligible Pfizer medications at no cost. Family-building benefits such as infertility treatment, adoption, and surrogacy support further reinforce the offering.
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Retirement Support — Retirement support includes a 401(k) with employer matching plus an additional company retirement contribution, alongside access to financial-planning resources. This combination is positioned as a meaningful part of total rewards.
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Leave & Time Off Breadth — Paid time off includes 15 holidays, three to six weeks of vacation depending on service, and the option to purchase additional vacation weeks, plus dedicated caregiver-leave days. Twelve weeks of paid parental leave and backup care resources add flexibility for family needs.
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
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