Precision Medicine Operations Lead - FSP
Employer · Parexel
R&D manager
Health services manager
BiologistFull-timeRemote
Munkáltató: Parexel. Pozíció: Operation Lead. The Precision Medicine Operations Lead will support clinical study teams as a subject-matter expert for technical and operational matters related to sample management, biomarker research, exploratory analysis, data acquisition, and human sample management flow.
Tasks
- 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
- Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer
- Oversees the acquisition and testing of clinical trial samples designated for biomarker research
- Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting
- Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported
- Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens
- Manage and oversee kit inventories, clinical sample collection, tracking and data query resolution
Requirements
- Strong project management and organization skills in a matrix environment
- Analytical and problem-solving experience
- Excellent written and verbal communication skills
- Fluent in speaking/writing English
- 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, if acting as programming lead
- 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
- Requires bachelor degree in life sciences or equivalent (science, technology, engineering, or mathematics) or relevant work experience