Skip to main content

Bioanalytical Study Lead

Job Description

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.

RESPONSIBILITIES

  • Provide oversight and conduct of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis.
  • Serve as Principal Investigator for GLP studies.
  • Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs.
  • Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business.
  • Provide project trackers for client communications and lead regular teleconferences to discuss project progress.
  • Coordinate customer visits and visit customers.
  • Work with business development staff to prepare quotes and change orders for assigned customers.
  • Prepare data for external presentations.
  • Work closely with Medical Writing and QA to ensure project deliverables are completed on schedule.
  • Monitor the progress of all assigned projects and alert management if work falls behind schedule.
  • Accountable for budget across assigned project(s) including financial performance targets.
  • Collaborate with finance to initiate monthly invoicing.
  • Meet financial performance targets for the assigned projects and proactively manage change order process both internally and externally.
  • Monitor project timeline and scope to ensure both remain on track; provide regular updates to management.
  • Participate in weekly scheduling and revenue update meetings and provide updates on project progress.
  • Ensure cross-functional collaboration among project team members including both internal and external services.
  • Serve as escalation point for project issues.
  • Resolve conflicts as needed.
  • Proactively identifies ways to increase client satisfaction.
  • Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
  • Define and manage project resources.
  • Ensure lessons learned are implemented across projects currently being managed.
  • Contribute to development and management of client project metrics.
  • Provide performance feedback of team members to respective supervisors.
  • Serve as a scientific lead for non-regulated, GLP-regulated, and GCP-regulated studies.
  • Review data (run binders, data tables, reports etc.) for regulatory compliance and scientific quality.
  • Review and approve bioanalysis plans.
  • Approve validation experimental designs and preparations.
  • Lead method troubleshooting efforts and scientific investigations with assistance from the method developer; document investigation report.
  • Address observations and findings from internal quality groups.
  • Conduct thorough investigations of all failed runs and runs with analytical issues.
  • Review validation and bioanalytical reports for completeness and scientific integrity.
  • Coordinate sample shipments and data deliverables with internal and external CROs.
  • Work with the customer or CRO to resolve sample discrepancies.
  • Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.
  • Ensure projects are archived in accordance with Q2 Solutions SOP.



REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Working knowledge of current regulatory guidelines (GLP, GCP)
  • Ability to achieve results through collaborative efforts with others.
  • Familiarity with liquid chromatography and combination with mass spectrometry or In vitro (Ithaca Site Location); Understanding of ligand binding and cell-based assays for Immunoassay and Immunogenicity (Marietta Site Location).
  • Understanding of routine laboratory procedures.
  • Understanding of method development and validation of assays.
  • Ability to describe clearly experimental objectives and data conclusions.
  • Proven ability to plan, prioritize, and manage a workload for large and complex projects
  • 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.


MINIMUM REQUIRED EDUCATION AND EXPERIENCE

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

PHYSICAL REQUIREMENTS

  • 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.


EEO Minorities/Females/Protected Veterans/Disabled

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.

Job ID: R1088829

Bioanalytical Study Lead

Ithaca, NY
Full Time

Published on 08/19/2019