Description
We are seeking an Associate BioServices Study Lead to join IQVIA Laboratories in Ithaca, NY, in a hybrid role.
As an Associate BioServices Study Lead, you will serve as the primary point of contact for external customers while providing scientific oversight throughout the lifecycle of bioanalytical projects. Working under Study Lead Management and in partnership with Project Management, you will ensure exceptional customer service and adherence to IQVIA scientific, quality, and regulatory standards.
Key responsibilities:
- Provide scientific oversight for method development, method validation, and sample analysis activities
- Serve as Principal Investigator for GLP studies and ensure compliance with applicable Good Clinical Practice and Good Laboratory Practice requirements
- Collaborate with Technical Writing, Quality Control, Quality Assurance, and Project Management to complete projects according to agreed schedules
- Review validation plans, sample analysis plans, experimental designs, analytical data, data tables, and bioanalytical reports for completeness, scientific quality, and regulatory compliance
- Maintain daily communication with customers, provide updates on active projects, resolve sample discrepancies, and coordinate and conduct customer visits
- Monitor project progress, provide status updates to management, escalate schedule risks, and submit accurate weekly assessments of resource requirements
- Investigate failed runs, address Quality Control and Quality Assurance findings, coordinate method troubleshooting, engage appropriate technical resources, and document investigation outcomes
- Partner with Business Development to prepare customer quotes, prepare data for external presentations, and ensure projects are archived according to IQVIA standard operating procedures
Requirements:
- Bachelor's Degree in a scientific field
- 3 years of related experience in a GLP laboratory environment
- Understanding of liquid chromatography combined with mass spectrometry, or in vitro and immunoassay techniques
- Experience with sample extraction and routine laboratory procedures
- Understanding of assay method development and validation
Nice to have:
- Ability to achieve results through collaborative efforts with scientific, quality, project management, business development, and customer teams
- Ability to interact effectively with internal and external clients while working to established objectives and timelines
- Excellent attention to detail and strong written and verbal communication skills
- Ability to follow verbally communicated procedures
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Benefits: 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.
Salary: $64,200.00 - $133,600.00 per year