Senior Bioservices Project Manager

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 IQVIA scientific standards.

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

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

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