Found Description
Role:
Within the Clinical Biomarker Laboratory, this role sits at the critical intersection of data integrity, regulatory compliance, and clinical development execution. You will act as a key quality control partner, ensuring laboratory data generated in GCP-regulated environments are inspection-ready, fully traceable, and aligned to regulatory expectations. Operating as an individual contributor, you will work hands-on with complex datasets, laboratory systems, and cross-functional stakeholders to uphold the highest standards of clinical data quality while supporting evolving digital and data-driven capabilities, including exposure to advanced data tooling and automation.
What You'll Do:
Within the Clinical Biomarker Laboratory, this role sits at the critical intersection of data integrity, regulatory compliance, and clinical development execution. You will act as a key quality control partner, ensuring laboratory data generated in GCP-regulated environments are inspection-ready, fully traceable, and aligned to regulatory expectations. Operating as an individual contributor, you will work hands-on with complex datasets, laboratory systems, and cross-functional stakeholders to uphold the highest standards of clinical data quality while supporting evolving digital and data-driven capabilities, including exposure to advanced data tooling and automation.
What You'll Do:
- Adhere to analytical data quality and integrity standards in accordance with MHRA, ICH, GCP requirements, applicable regulations, and established SOPs across clinical studies
- Perform comprehensive QC review of raw laboratory data (paper records, ELNs, instrument ...