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.
Essential Functions
? Maintain Lab directory of service and associated global test codes. Support regional cost sheets and price sheets.
? Maintain strong internal and external relationships, including global pathologists.
? 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.
? Supports Sales in bid preparation and defense.
? 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
Qualifications
? Bachelor's Degree equivalent combination of education, training and experience Req
? 3-5 years relevant industry experience
? ? 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. QLIMS, NewLIMS, QNET); Strong knowledge of lab safety; Proficient in Microsoft Office