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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing lab data within clinical trials, including the creation and maintenance of Lab IDs, adherence to CDISC standards, and proficiency in EDC systems. Strong communication and project management skills are essential for collaborating with study teams and ensuring accurate data reporting.
Highest-signal resume keywords
Lab Data ManagementCDISC Standards ImplementationClinical Data ManagementEDC System ExperienceLaboratory Data Collection
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Lab ID CreationData ReviewSafety Lab Data SolutionsRelational Database ExperienceData Visualization Tools
Soft Skills
Strong Communication SkillsDecision-MakingInfluencing SkillsNegotiation SkillsProject Management
Tools & Technologies
Microsoft Office SuiteOracleSpotfireJ ReviewLab Normal Management Tool
Industry Keywords
PharmaceuticalBiotechCRORegulatory AgencyDrug Development Process
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Review protocol and lab CRFs during study set up phase
- Ensure Lab Normal Management Tool is configured accurately according to protocol and lab CRFs
- Create protocol-specific templates to capture missing lab parameters
- Review lab slips and reference-range documents and create Lab IDs in EDC systems
- Maintain Lab IDs and update normal reference ranges in the database
- Support Local and Central lab IDs for Pfizer studies
- Create and maintain Lab Test Questions Library, lab test units, SI-unit conversions, conversion formulas, and preferred copy groups
- Handle textbook reference range requests and updates
- Assign lab codes to tests for lab data received through CRFs or electronic transfer
- Collaborate with Data Acquisition to map vendor test codes to internal test codes
- Develop, maintain, and update lab-related SOP documents and guidelines
- Support implementation of CDISC lab data standards and LOINC codes
- Serve on the data standards board and lead implementation or development of safety lab data standards as needed
- Support lab CRF design changes, testing, and UAT for safety lab data derivations and validations
- Guide study management in collecting complete and accurate reference-range documents from investigator sites
- Guide study teams and data managers in assigning Lab IDs and resolving assignment issues
- Serve as technical SME for analysis and remediation of lab data discrepancies
- Serve as technical SME for creating new Lab Data listings and reports from Pfizer tools and applications
- Test new or updated Lab Data listings and CTCAE grade reports
- Review lab reconciliation reports and recommend actions to resolve lab data issues
- Collaborate with partners, colleagues, and Clinical Data Scientists on standards, data-cleaning reports, and DMM deliverables
- Develop study-team knowledge of safety lab data from local and central labs
- Drive process improvements and lead organizational initiatives
- Measure and publish Lab ID creation cycle-time and productivity metrics
Requirements
What you’ll need- 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)
- Primarily an office-based position involving sitting in front of a computer for large periods of work time and making presentations
- Work Location Assignment: On Premise
Benefits
Comp & perks- Equal opportunity employer
- Ability to travel ~5%