Medical Laboratory Director (R1067567) in Valencia, CA at IQVIA™

Date Posted: 7/21/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Valencia, CA
  • Experience:
    Not Specified
  • Date Posted:
    7/21/2019
  • Job ID:
    R1067567

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.

PURPOSE

The Medical Laboratory Director, Valencia, CA, is the regulatory Laboratory Director of the Valencia, CA laboratory of Q Squared Solutions. The Valencia clinical trials laboratory is a College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA) licensed, California licensed, and NYS-permit laboratory and performs a wide variety of clinical and anatomic pathology analyses as well as some other biomarker testing such as genomics, immuno-assays and flow cytometry on samples from patients participating in pharmaceutical clinical trials throughout the Americas and ex-US. This position primarily focuses on “Clinical Pathology” whilst the Anatomic Pathology scientific oversight, services, testing, and reporting are supported by the Anatomic Pathology Discipline Director, the “Chief Pathologist,” and the local AP Director and team.

RESPONSIBILITIES

  • Maintain the standards of the College of American Pathologists and hold the CAP accreditation.
  • Maintain and hold the California clinical lab license, CLIA clinical lab license and the NYSDOH testing permit and support;
  • Ensure to hold and maintain as many or all Certificate of Qualification (CoQ) areas or ensure that proper CoQ are obtained by other employees to be compliant;
  • Ensure an effective quality management program for the laboratory;
  • Ensure that proficiency testing and QC procedures are sufficient for the purpose and extent of testing in the laboratory;
  • Ensure communication of laboratory data and patient result reporting is appropriate and actionable;
  • Ensure provision of consultations regarding the ordering of tests and medical significance of laboratory data;
  • Ensure provision of educational programs and research and development that is appropriate to the needs of the laboratory;
  • Ensure sufficient numbers of personnel with appropriate education qualifications, documented training and experience and adequate competency and proficiency to meet the needs of the laboratory;
  • Ensure a safe laboratory environment while working with the EHS representative;
  • Interact with US federal and state regulatory bodies, such as CMS, NYSDOH, California, FDA as appropriate;
  • Ensure global combinability of clinical laboratory data per sponsor requirements;
  • Ensure test codes, medical reporting, and LIS changes impacting clinical lab reporting are approved and actionable.
  • Work with global harmonization teams for test codes, operations, instrumentation, science, to ensure standardization and harmonization such that test results from Q2 sites are combinable.
  • Be a thought leader in the application of laboratory and analytical science to the provision of central clinical trials laboratory services for Phase 1-4 Clinical Trials;
  • Provide laboratory science and regulatory support to the CSO, scientific advisors, directory of services, technical services, global technical and scientific harmonization teams, the project services and scientific sales teams;
  • Review and assess Event-Driven Analysis (EDA) issues that are determined to be major or critical for patient safety or study efficacy or data integrity impact;
  • Attend bid defense virtual meetings with sponsors of clinical trials;
  • Provide support to investigating issues relating to laboratory testing;
  • Provide support to the technical services team for pre-analytical, analytical, and post-analytical procedures and issues;
  • Discuss laboratory findings with sponsors and/or clinical trial investigators as required;
  • Respond by email or telecon to sponsors and investigators regarding issues they may ask or uncover

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • In depth knowledge of clinical pathology testing procedures and applicable laboratory testing regulations for CAP, CLIA, California, New York State;
  • Working knowledge of quality assurance and quality control and continuous improvement principles;
  • Experience with and ability to understand, analyse, and work with complex laboratory LIS and laboratory trial management systems to deliver harmonized services and clinical laboratory results globally;
  • Knowledge of occupational health and safety (OSHA) rules and regulations for the clinical laboratory;
  • Excellent client management and problem resolution skills;
  • High ethical standards and integrity;
  • Strong ability to work with laboratory operations for efficiency and effectiveness;
  • Ability to assess and prioritize multiple tasks, projects and demands;
  • Ability to make effective and persuasive presentations on controversial or complex topics to internal or external clients, senior management and other stakeholders;
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients;
  • Excellent written and oral English communication skills;
  • Experience with computer systems and use of software including document, spreadsheet, presentation, e-mail, calendar, messaging, LIS reporting, Skype, Outlook, Microsoft, smartphone, and data query systems;
  • Solid knowledge of clinical laboratory statistics use, application and interpretation;
  • Must be open to travelling including internationally;

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • The role requires qualifications acceptable by the CMS (Center for Medicare and Medicaid Services, US DHHS) to serve as Laboratory Director for a CLIA (Clinical Laboratory Improvement Amendments) high complexity laboratory as well as California licensed and NYS CQ eligible preferred
  • If PhD, have a US HHS approved board certification in a clinical laboratory science; or if MD or DO: American Board of Pathology Board Certified in Clinical Pathology or both Anatomic and Clinical Pathology and possess a current and unrestricted license to practice medicine in California, MD or DO;
  • Be familiar with GC(L)P and ISO15189 and have experience maintaining accreditation of clinical and/or anatomic pathology laboratories; and the pharma drug development process encompassing phases I-IV as well as “biomarkers;”
  • The PhD or MD/DO with 10+ years relevant clinical laboratory experience including at least 2 years managing staff; or equivalent combination of education, training and experience;
  • 5+ years working in a central lab organization providing clinical lab testing services for pharmaceutical drug development in humans;
  • Ongoing maintenance of Continuing (Medical) Education (CE) hours/credits to meet licensure or business requirements;
  • Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.

PHYSICAL REQUIREMENTS         

The bullets listed below are examples of typical physical requirements for many jobs.  Please remove or add requirements as necessary.

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

• Extensive use of keyboard requiring repetitive motion of fingers and smartphone screen use and typing

• Regular sitting for extended periods of time

• Work is performed in a clinical laboratory environment, full manual dexterity and visual acuity is required

• May be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment

• Occasional travel including international

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: R1067567