Senior Precision Medicine Operations Lead
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Job Description
Senior Precision Medicine Operations Lead at Parexel enhancing clinical trial solutions through operational support and cross-functional collaboration. Driving biomarker research and ensuring compliance with protocols.
Responsibilities:
- 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.
Requirements:
- 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.
Benefits:
- Health insurance
- Professional development opportunities
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