Associate BioServices Study Lead - Hybrid

IQVIA; Indianapolis (IN); 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 through bioanalytical projects, partnering with PM, Medical Writing, QC, QA to meet regulatory and scheduling requirements.

You will lead method development and validation, supervise GLP studies, review reports, manage project status, and maintain client communications while adhering to GCP/GCP standards.

Qualifications

• 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

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

GLP Laboratory Experience

LC-MS Understanding

Sample Extraction

Method Development

Communication Skills

Education

Bachelor’s Degree in Scientific Field

Job description

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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.