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IQVIA

Runs drug trials and sells health data to pharma

Associate Bioservices Study Lead

Biology & BiotechConfirmed live in the last 24 hours
Full-timeIthaca, NY, USAHybrid

About the Job

Requirements

  • A bachelor's degree in a scientific field, or an equivalent combination of education, training, and experience.
  • Three 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.
  • Ability to achieve results collaboratively 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.
  • Strong attention to detail and written and verbal communication skills.
  • Ability to follow verbally communicated procedures.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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.

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size
10,001+
Company stage
IPO
Headquarters
Durham, NC
Founded
1998

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