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Clinical Laboratory Study Manager
ParexelClinical Laboratory Study Manager overseeing cross-functional teams to manage sample quality and data in clinical trials. Collaborating with stakeholders to execute precision medicine strategies.
Tech Stack
Tools & technologiesGoogle Cloud PlatformLinuxPerlPythonSQLUnix
About the role
Key responsibilities & impact- Works closely with Precision Medicine Leadership and cross-functional study teams to ensure quality samples and data are proficiently managed
- Participate in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
- Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing
- Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
- Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens
Requirements
What you’ll need- 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, as well as relevant role specific systems
- 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 for supplies and laboratory operations
- Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
- Flexible work arrangements
ATS Keywords
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Hard Skills & Tools
clinical researchbiosample process planningdata managementsample managementclinical drug developmentprogramming in Pythonprogramming in Rprogramming in Perlprogramming in SQLAPIs
Soft Skills
communicationcollaborationtrainingguidanceleadership