requests and studies, including oversight of technical processes and procedures insofar as they impact pathology interpretations. Perform microscopic analyses of laboratory assays and monitor digitization of slides. Correlate clinical information with pathology findings. Release timely reports into LIMS for sponsor and/or clinical site action. Participate in internal and client-facing communications. Interact collegially with other pathologists, customers, vendors and employees in order to achieve shared goals.; Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Essential Functions
• Review and score Immunohistochemistry and FISH slides.
• As part of a team, establish new histopathology assays in the laboratory.
• Provide pathologist input to discussions with clinical trial sponsors to ensure delivery of the goals of the clinical trial in an efficient and cost-effective manner, ensuring that the highest standards of quality and customer service are maintained.
• Maintain professional qualifications and accreditations in line with relevant authorizing bodies and continuing professional development.
• 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.
• Other duties as assigned.
Qualifications
• Other Medical degree or foreign equivalent at the Licensed Physician level and certification in anatomic pathology Req
• Typically requires 3 - 5 years of prior relevant experience or equivalent combination of education, training and experience.
• Preferred experience working in a reference lab, clinical research organization, and/or clinical trials.
• Excellent written and oral communication skills.
• Excellent client management and problem resolution skills.
• Knowledge of PC applications.
• High ethical standards.
• Ability to meet average industry performance metrics, as well as metrics outlined by the company.
• Proficient in routine histopathology testing, immunohistochemistry (IHC), cytogenetics (In-situ hybridization) testing procedures and applicable laboratory testing regulations.
• Working knowledge of quality assurance and quality control principles and in-depth knowledge of company-specific program requirements.
• 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.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to bring projects and deliverables to completion under timeline expectations.
• Knowledge of occupational safety and health rules and regulations.
• Other Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.