Work closely with Precision Medicine Leadership and cross-functional study teams
Ensure quality samples and data are proficiently managed to support biomarker and non-biomarker evaluation
Participate in cross-functional study team meetings and workstreams
Supports project management and study set-up teams in the creation and validation of specialty laboratory databases
Manages all activities related to biosample 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 6 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
Proficiency in Microsoft Office applications, including strong excel knowledge
Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments
Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience

Clinical Laboratory Study Manager

Key skills