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Senior Bioanalytical Project Manager/Principal Investigator

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Primary Location: Durham, North Carolina, United States Full time R1289792

Job description

Job Overview
The BioServices Project Manager is the primary point of contact for our external customers.  The focus of the BioServices Project Manager is to provide exceptional customer service while ensuring that all work meets Q² scientific standards.

RESPONSIBILITIES

  • Provide oversight and conduct of a project throughout its life at Quintiles, including method development, method validation, and sample analysis.
  • Serve as Principal Investigator for GLP studies.
  • Work closely with Technical Writing and QA to ensure projects are completed on schedule. Review validation and bioanalytical reports for completeness. Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business.
  • Work with the customer to resolve sample discrepancies.
  • Monitor the progress of all assigned projects and alert management if work falls behind schedule.
  • Provide regular project status updates to management.
  • Participate in weekly scheduling and revenue update meetings and provide updates on project progress.
  • Submit accurate weekly assessment of resource requirements  for scheduling purposes.
  • Prepare validation and sample analysis plans.
  • Review data (run binders, data tables, etc) for regulatory compliance and scientific quality. Address issues from QC and QA review for run binders.
  • Conduct thorough investigations of all failed runs.
  • Lead method troubleshooting investigations. Assemble group of pertinent technical resources and write up investigation report.
  • Provide project trackers for client communications and lead regular teleconferences to discuss project progress.
  • Coordinate customer visits. Visit customers.
  • Work with business development staff to prepare quotes for assigned customers. Approve validation experimental designs.
  • Prepare data for external presentations.
  • Ensure projects are archived in accordance with Quintiles SOP.
  • Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's Degree scientific field
  • 5 years’ related experience. Equivalent combination of education, training and experience in GLP laboratory environment.

REQUIRED KNOWLEDGE,SKILLS,AND ABILITIES

  • Ability to achieve results through collaborative efforts with others.
  • Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay techniques.
  • Experienced in sample extraction and routine laboratory procedures.
  • Understanding of method development and validation of assays.
  • Ability to interact with external and internal clients, and work to objectives/timelines.
  • Excellent attention to detail and communication skills.
  • Ability to provide verbally communicated or draft procedures.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Ability to achieve results through collaborative efforts with others.
  • Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay techniques.
  • Experienced in sample extraction and routine laboratory procedures.
  • Understanding of method development and validation of assays.
  • Ability to interact with external and internal clients, and work to objectives/timelines.
  • Excellent attention to detail and communication skills.
  • Ability to provide verbally communicated or draft procedures.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

“I know Q2 Solutions offers me a great career path with lots of options. My line manager fully supports my growth.”

Marianne H, Associate Laboratory Project Set-Up Manager

“There are tremendous opportunities to grow here. If you are driven, passionate and committed, the sky’s the limit.”

P. Surve, Clinical Process Team Lead

“What gets me most excited about being part of Q2 Solutions is working with cutting-edge technologies that help patients and further innovation in the field.”

Todd L., Scientist

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