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