Bioanalytical Study Lead: GLP Oversight (Hybrid)

IQVIA LLC; Indianapolis, Northern (IN, KY); Hybrid; USD 64,000 - 134,000; Full time

Job summary

IQVIA Laboratories in Indianapolis, IN seeks an Associate BioServices Study Lead - Hybrid to provide scientific oversight across bioanalytical projects, partnering with Project Management, Medical Writing, Quality Control, and Quality Assurance to ensure projects meet scientific, regulatory, and scheduling requirements.

You will lead method development and validation, serve as PI for GLP studies, review reports for regulatory and scientific quality, monitor progress, troubleshoot issues, and

Qualifications

• Bachelor's Degree in a scientific field with 3 years’ related experience.
• Equivalent combination of education, training and experience in GLP laboratory environment.

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 for completeness and address findings from Quality Control and Quality Assurance reviews
• Monitor assigned projects, communicate status updates, and elevate schedule risks to management
• Investigate failed runs, coordinate method troubleshooting, assemble technical resources, and document investigation findings
• Maintain communication with customers, resolve sample discrepancies, coordinate customer visits, and support quote preparation
• Ensure projects are archived in accordance with IQVIA SOPs and comply with applicable Good Clinical Practice and Good Laboratory Practice standards

Skills

Collaboration

Attention to detail

Written communication

Client interaction

Cross-functional partnership

Education

Bachelor's degree in scientific field

Job description

IQVIA Laboratories in Indianapolis, IN seeks an Associate BioServices Study Lead - Hybrid to provide scientific oversight across bioanalytical projects, partnering with Project Management, Medical Writing, Quality Control, and Quality Assurance to ensure projects meet scientific, regulatory, and scheduling requirements.

You will lead method development and validation, serve as PI for GLP studies, review reports for regulatory and scientific quality, monitor progress, troubleshoot issues, and