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Vaccines Project Leader

Location: Durham, North Carolina
R1225755

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Our Central Laboratories Project Managers are key members of the Global Project Services team, and play a vital role in the design, launch, and management of the clinical studies that we lead. When you join us, you’ll have the opportunity to grow and develop your career, while working with some of the brightest scientists and thought leaders in the industry.

  • Full Time
  • Level: Mid-level
  • Travel: Yes
  • Glassdoor Reviews and Company Rating

Career path

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Quote

Q2 offers a robust development plan for CRAs, including trainings, mentorship programs, and cross-functional career meetings. These conditions made me feel ready, confident, and well-trained to execute the role a CRA with quality and integrity.1

Alberto, Clinical Research Associate 2

Vaccines Project Leader

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Location: Durham, North Carolina, United States R1225755 Posted: 10/12/2021

Job description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. 

Responsibilities

  • Plan day to day activities for assigned projects. Create work lists for laboratory staff. Request samples from Laboratory Operations for analysis. Provide daily direction and feedback to laboratory staff.
  • Import and process run data in Watson. Accept or reject run results.
  • Work with Project Manager to investigate failed runs and runs with analytical issues.
  • Write up analytical results and assemble run binders.
  • Submit accurate weekly assessment of resource requirements for scheduling purposes.
  • Attend weekly scheduling and revenue update meetings and provide updates on project progress. Maintain run trackers for assigned projects. Provide timely MS timesheets for study tracking.
  • Review data (run binders, data tables, etc.) for regulatory compliance and scientific quality.
  • Track supply and expiration of project related materials (LC columns, reference compounds, stock solutions, etc.) Assemble data tables for client submission. Design validation experiments to direct wet lab staff. Archive all studies in a timely manner in accordance with Q2 SOP.
  • Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

Minimum required education and experience

  • Bachelor's Degree in a Scientific field required.
  • 1 year of related experience or equivalent combination of education, training, and experience in a GLP laboratory environment.

Required knowledge, skills and abilities

  • Understanding of vaccines or Immunoassay techniques.
  • Understanding of sample extraction and routine laboratory procedures.
  • Understanding of method development and validation of assays.
  • Ability to interact with internal clients, and work to objectives/timelines.
  • Excellent attention to detail and communication skills.
  • Ability to follow verbally communicated or draft procedures.
  • Ability to describe clearly experimental objectives and data conclusions.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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