Lab Data Specialist I

The Lab Data Specialist I (LDS I) is responsible for supporting oversight of clinical specimens and associated laboratory data collected throughout the life of a clinical trial, including safety labs, Pharmacokinetics, biomarkers, tumor samples, etc. and will assist in departmental infrastructure development. The LDS I will engage with cross-functional team members while developing data management skills and helping coordinate lab vendor start-up and study maintenance with support and oversight. The LDS I has at least a preliminary understanding of clinical laboratory/ biomarker testing, lab specimen handling and lab data reconciliation. A working knowledge of FDA regulations and general industry standards is desired.

• Supports laboratory data management procedures including authoring and reviewing data transfer plans, overseeing data transfers, processing and storage of data.
  • Uses templates and standard guidelines to initiate documents but exercises critical thinking and discretion to tailor documents to study needs.
• Supports data cleaning activities for lab data reconciliation. Researches and resolves discrepancies of moderate complexity.
• Assists lead Biomarker Data Specialists to create detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure meet end user needs.
• With guidance, assists in managing multiple project streams by coordinating with internal and external stakeholders concerning timelines and deliverables.
  • Internal stakeholders may include Client Clinical Pharmacologists, Biomarker & Bioinformatics scientists, Clinical Specimen Coordinators, Clinical Project Managers and others.
  • External stakeholders may include vendor representatives such as Project Managers, Data Analysts and others.
• Advises and coordinates with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders regarding timelines and deliverables
• Works with internal and external stakeholders to coordinate specimen testing in accordance with study plans and timelines.
• Maintains an integrated tracking and inventory log of all specimens collected during a clinical trial, interpret data and share metrics with stakeholders.
• Conducts data cleaning activities for vendor data reconciliation with minimal guidance. Exercise discretion and seek guidance as needed to choose efficient and effective issues resolution paths.
• With some oversight, creates detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure that meet end user needs.
• Runs SAS programs, review SAS logs, and generate output.
• Utilizes problem-solving skills when working with vendors and collaborators to drive projects forward, seeking guidance when needed.
• Drafts, revises, and provides feedback on contracts and study documents to ensure alignment with stakeholders needs, internal processes and vendor capabilities.
• Works with external labs and internal stakeholders to troubleshoot issues and implement process improvements of moderate scope.
• Assists in maintenance of department tools, templates, and systems.
• Completes assigned training, including general training requirements, Policies, Standard Operating Procedures (SOPs), system, and process-related training
• Adheres to applicable Policies, SOPs, and processes
• Demonstrates commitment to Parexel’s FSP Mission, Vision, and Values, and Parexel’s “We Care” Core Values

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.