Associate BioServices Study Lead - Hybrid

IQVIA Laboratories; Indianapolis (IN); Sur place; USD 64 000 - 134 000; Plein temps

Résumé du poste

IQVIA Laboratories in Indianapolis, IN seeks an Associate BioServices Study Lead - Hybrid to oversee bioanalytical projects from method development through reporting, ensuring GLP compliance and client satisfaction.

You will partner with Project Management, Medical Writing, Quality Control, and Quality Assurance to meet scientific, regulatory, and scheduling requirements while maintaining strong client communication.

Qualifications

• Bachelor's degree in a scientific field is required.
• 3 years of GLP laboratory experience or equivalent.
• Understanding of liquid chromatography with mass spectrometry or immunoassay techniques.

Responsabilités

• Provide scientific oversight for method development, validation, and sample analysis.
• Serve as Principal Investigator for GLP studies and ensure regulatory compliance.
• Coordinate plans, data review, and risk communication with stakeholders.
• Maintain client communication and support quote preparation.

Connaissances

Collaboration

Attention to detail

Written and verbal communication

Formation

Bachelor's Degree in Scientific field

Outils

LC-MS

Immunoassays

Description du poste

We are seeking an Associate BioServices Study Lead - Hybrid to join IQVIA Laboratories at Indianapolis, IN.

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

Job Summary

Provide scientific oversight throughout the lifecycle of bioanalytical projects while delivering exceptional service to internal and external customers. Partner with Project Management, Medical Writing, Quality Control, and Quality Assurance to ensure projects meet scientific, regulatory, and scheduling requirements.

What You'll Be Doing

• 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

What We Are Looking For

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

The Knowledge, Skills And Abilities Needed For This Role

• Ability to achieve results through effective collaboration with colleagues and cross-functional partners
• Excellent attention to detail, scientific judgment, and written and verbal communication skills
• Ability to interact effectively with internal and external clients while working to defined objectives and timelines
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

What We Offer You

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees' physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit https://jobs.iqvia.com/benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $64,200.00 - $133,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.