Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy.
Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing.
Works with clinical study teams on the development and review of sample-related sections of study-specific documents.
Supports project management and study set-up teams in the creation and validation of specialty laboratory databases for data collection and sample kit tracking.
Manages all activities related to bio sample process planning and execution.
Oversees the acquisition and testing of clinical trial samples designated for biomarker research.
Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials.
Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens.

Minimum of 8 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry.
Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable.
Science background with significant working knowledge of biological assays.
Fluent in speaking/writing English.

Senior Precision Medicine Operations Lead

Key skills