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Associate BioServices Study Lead - Hybrid

IQVIA
  • Indianapolis, Indiana
    9 days ago

    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 escalate 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.

    If you're looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible!

    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.

    Numbers & Facts

    LocationIndianapolis, Indiana
    IndustryHealthcare Services
    Company Size10,000 employees or more
    Year Founded1982
    Websitehttps://www.iqvia.com/

    About Company

    IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.

    Skills

    • Analysis Skillsunmatched
    • Assay Developmentunmatched
    • Assay Methodsunmatched
    • Biologyunmatched
    • Clinical Researchunmatched
    • Communication Skillsunmatched
    • Cross-Functionalunmatched
    • Detail Orientedunmatched
    • Develop and Maintain Customersunmatched
    • Experiment Designunmatched
    • GCP (Good Clinical Practices)unmatched
    • GLP (Good Laboratory Practices)unmatched
    • Healthcareunmatched
    • Identify Issuesunmatched
    • Immunoassaysunmatched
    • Laboratoryunmatched
    • Laboratory Techniquesunmatched
    • Liquid Chromatography-Mass Spectrometry (LC-MS)unmatched
    • Medical Treatmentunmatched
    • Medical Writingunmatched
    • Patient Careunmatched
    • Presentation/Verbal Skillsunmatched
    • Project Lifecycleunmatched
    • Project Trackingunmatched
    • Project/Program Managementunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Research & Development (R&D)unmatched
    • Risk Managementunmatched
    • Service Deliveryunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Technical Writingunmatched
    • Writing Skillsunmatched

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