Associate BioServices Study Lead
IQVIA · Ithaca, United States +1 · 1mo ago
We are seeking an Associate BioServices Study Lead to join IQVIA Laboratories in Ithaca, NY, in a hybrid role.
Job Summary:
What You'll Be Doing:
- 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
What We Are Looking For:
- 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
- Other equivalent combination of education, training, and experience may be accepted in lieu of degree
The Knowledge, Skills and Abilities Needed for This Role:
- 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
What We Offer You:
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.