LCMS Lead Scientist

JOB OVERVIEW

Supports the day-to-day operations of the assigned Lab, 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 Lab directory of service and associated global test codes.
• Maintain strong internal and external relationships.
• 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.
• 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 assigned Lab services.
• 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 EDUCATION REQUIRED AND EXPERIENCE

• Bachelor's Degree equivalent combination of education, training and experience Required.
• 3-5 years relevant industry experience.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Deep scientific knowledge/experience with the ability to troubleshoot.
• Strong knowledge of relevant procedures, processes, and regulations.
• Working knowledge of department systems (i.e., QLIMS, NewLIMS, QNET).
• Strong knowledge of lab safety.
• Proficient in Microsoft Office.

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. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status