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Manager, Medical Labs- Molecular Biology

IQVIA Holdings Inc.

Valencia, California

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

Supports the day to day operations to labs supporting, to deliver on sponsor requests and studies, including pre-award and post award support. Perform work in accordance with ICH E6 Guideline for Good Clinical Practice.

Responsibilities

  • Maintain department directory of service and associated global test codes. Support regional cost sheets and price sheets.
  • Maintain strong internal and external relationships, including global site heads.
  • Management, oversight and coordination of the transition of clinical trials tests from development into global operations.
  • Ensure reliable, secure global procedures are developed, maintained and documented for new tests being implemented.
  • Supports Scientific Affairs and Sales in the acquisition of new testing
  • Review and approve quality control reports used to assess the validity of testing procedure, initiate remedial/corrective action where indicated.
  • Reviews existing department procedures and makes appropriate recommendations to global Lab Operations Managers.
  • Assists Scientific Affairs regarding technical requests including technical principles, advice on choice of tests, test development, cost of testing and result interpretation.
  • Provide clear and timely communications lines with Test Development, Scientific Affairs, Project Management, Pharmaceutical sponsors, laboratory operations, and investigators to ensure global services are developed and appropriate with all regulatory and customer requirements.
  • Develop a good understanding of the Q2 Solutions business and build relationships with global scientists and global laboratory operations.
  • Provide oversight to ensure reliable secure global technical and operational procedures are in place and provide support for improvement opportunities globally.
  • Remain aware of scientific and other advances, as the subject matter expert for department
  • Develop and maintain skills and knowledge appropriate to the post by undertaking training and attending meetings and conferences.
  • Ensures that safety, environmental, company and departmental policies and procedures are disseminated, understood, complied with and documented.
  • Ensure that employees receive appropriate training in working practices in line with local regulatory bodies.
  • All associates will be familiar with the safety, environmental rules and procedures applying to their job and take reasonable care for their own safety and that of other people.
  • Understand and apply the site Safety, Environmental Policy, Safety Management System and relevant legal safety  & Environmental requirements

Minimum required education and experience

• Bachelor's Degree  Preferred

Required knowledge, skills and abilities

  • Deep scientific knowledge/experience with the ability to troubleshoot, guide and provide direction/performance management of staff as well have an understanding of operating budget and impacts to overall P&L. Skilled in extracting data to measure KPI's; Strong knowledge of relevant procedures, processes, and regulations; Working knowledge of department systems (i.e. QLIQVIA, NewLIQVIA, QNET); Strong knowledge of lab safety; Proficient in Microsoft Office
  • Excellent communication (interpersonal, verbal and written) skills, ability to communicate effectively at all levels.
  • Knowledge of PC applications
  • Ability to work with global teams
  • Ability to travel
  • Knowledge of Health/Safety and Environment good practice.
  • Duty to comply with all applicable standards as required by the company

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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 posted: 2021-04-26

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