Associate BioServices Study Lead at IQVIA | Ithaca, NY, US | Rezi

Associate BioServices Study Lead at IQVIA

Associate BioServices Study Lead

IQVIA · Ithaca, NY, US

4 weeks ago

Associate BioServices Study Lead

IQVIA · Ithaca, NY, US

a month ago
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About the Role

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, ensure exceptional customer service and adherence to IQVIA scientific, quality, and regulatory standards.

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

  • 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

Skills

  • 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
  • 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

Location

  • Ithaca, NY

Work Type

  • Hybrid

Experience Level

  • Associate

Education Level

  • Bachelor's Degree in a scientific field
  • Other equivalent combination of education, training, and experience may be accepted in lieu of degree

Salary/Compensations

  • $64,200.00 - $133,600.00

Benefits

  • Integrated benefits programs and resources to take care of employees' physical, mental and emotional, financial and social well-being

About the Company

  • IQVIA Laboratories hires passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration.
  • 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.

Equal Opportunity

  • 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.