IQVIA
Life sciences
AssocBioSvcsProjectMgr
Neural analysis suggests this role is
optimal for Mid candidates.
“Assoc BioSvcs Project Mgr at IQVIA. Skills: Project management, Customer service, GLP studies. Provide oversight of project. Conduct project”
Industry & Context.
Troubleshooting investigations; Failed runs investigation
What They're Looking For.
Must Have
Bachelor's Degree Scientific field, 3 years’ related experience, GLP laboratory environment experience, Ability to interact with external and internal clients, Ability to work to objectives/timelines, Ability to follow verbally communicated procedures, Ability to establish and maintain effective working relationships
Nice to Have
Understanding of liquid chromatography and combination with mass spectrometry, Understanding of In vitro and Immunoassay techniques, Experienced in sample extraction, Experienced in routine laboratory procedures, Understanding of method development of assays, Understanding of validation of assays
What You'll Do.
Provide oversight of project
Serve as Principal Investigator
Work closely with Technical Writing and QA
Review validation reports
Review bioanalytical reports
Maintain communication with customers
Provide daily updates
Resolve sample discrepancies
Monitor project progress
Alert management if work falls behind schedule
Provide project status updates to management
Submit assessment of resource requirements
Prepare validation plans
Prepare sample analysis plans
Address issues from QC and QA review
Conduct investigations of all failed runs
Organize method troubleshooting investigations
Assemble technical resources
Write investigation report
Coordinate customer visits
Prepare quotes for customers
Approve validation experimental designs
Prepare data for external presentations
Ensure projects are archived
Comply with regulatory standards
How You'll Work.
Team & Collaboration
Collaborative efforts with others
Communication Scope
Customer communication; Project updates; Status updates; Customer visits
Process & Methodology
Project management
Full Job Description
Job Overview The Assoc. 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 IQVIA 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 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. 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 Quintiles SOP. Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices. Qualifications • Bachelor's Degree Scientific field Req • 3 years’ related experience. Equivalent combination of education, training and ex
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