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Immunoassay Bioanalytical Project Manager(Beijing) - (1705315) in Beijing, CN at IQVIA™

Date Posted: 3/11/2018

Job Snapshot

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.


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


•         Provide oversight and conduct of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis.

•         Work closely with Method Development, Technical Writing, QC, 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 Q2 Solutions SOP

Job Requirements


•          Ability to achieve results through collaborative efforts with others.

•          Understanding of Ligand binding assays and Immunoassays for large molecule PK and Immunogenicity analysis.

•          Experienced with conducting PK and Immunogenicity assays including cut point setting.

•          Understanding of statistics and its application to data analysis

•          Understanding of method development, validation, and sample analysis of PK and Immunogenicity 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.


Bachelor’s Degree in Biology, Biochemistry, or related scientific field with 5 years’ related experience; or equivalent combination of education, training and experience in GLP laboratory environment.


•          Extensive use of keyboard requiring repetitive motion of fingers.

•          Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

•          Regular sitting for extended periods of time.

•          Some travel required.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: 1705315


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