Associate BioServices Study Lead (Hybrid)

About the role

IQVIA Laboratories in Indianapolis is seeking an Associate BioServices Study Lead on a hybrid basis. The role provides scientific oversight throughout the lifecycle of bioanalytical projects, serving internal and external customers and partnering with Project Management, Medical Writing, Quality Control and Quality Assurance to meet scientific, regulatory and scheduling requirements.

Key responsibilities

• Provide scientific oversight for method development, method validation and sample analysis projects
• Serve as Principal Investigator for GLP studies
• Prepare validation and sample analysis plans, approve experimental designs and review data for regulatory compliance and scientific quality
• Review validation and bioanalytical reports and address findings from Quality Control and Quality Assurance reviews
• Monitor assigned projects, update customers and escalate schedule risks to management
• Investigate failed runs, coordinate method troubleshooting and document investigation findings
• Maintain customer communication, resolve sample discrepancies, coordinate customer visits and support quote preparation
• Archive projects according to IQVIA SOPs and comply with Good Clinical Practice and Good Laboratory Practice

Required profile

• Bachelor's degree in a scientific field
• 3 years of related experience, or an equivalent combination of education, training and experience in a GLP laboratory environment
• Collaborative, detail-oriented with strong written and verbal communication skills

Required skills

• Understanding of liquid chromatography combined with mass spectrometry, or in vitro and immunoassay techniques
• Experience with sample extraction, routine laboratory procedures, assay method development and assay validation

What we offer

• Integrated benefits covering physical, mental and emotional, financial and social well-being
• Base pay range of $64,200 to $133,600 per year, depending on qualifications, location and schedule