Associate BioServices Project Manager, In Vitro

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.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Overview
The Associate BioServices Project Manager is the primary point of contact for our external customers.  The focus of the Assoc. BioServices Project Manager is to provide exceptional customer service while ensuring that all work meets Q2 Solutions scientific standards working under the direction of senior members of the BioServices Project Management team.

Essential Functions

• Provide oversight and conduct of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis.
• Work closely with QA/QC 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. 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.
• 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. Organize method troubleshooting investigations.
• Assemble group of pertinent technical resources and write up investigation report.
• 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 Q² Solutions SOPs.
• Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

Qualifications

• Bachelor's Degree Scientific field
• 3 years’ related experience. Equivalent combination of education, training and experience in GLP laboratory environment.
• 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 follow verbally communicated 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.
• Ability to follow verbally communicated procedures.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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.