Assoc Laboratory Manager (Molecular)

ROLE:

Supports the day to day operations to labs supporting, 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.

Key responsibilities include:

• Maintain department directory of service and associated global test codes. Support regional cost sheets and price sheets.
• Maintain strong internal and external relationships, including global site heads.
• 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.
• Reviews existing department procedures and makes appropriate recommendations to global Lab Operations Managers.
• Assists Scientific Affairs regarding technical requests including technical principles, advice on choice of tests, test development, cost of testing and result interpretation.
• 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 department  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

The ideal candidate should possess the following:

• A Bachelors degree in Biomedical/Biological/Pharmaceutical Science (or related) 
• Demonstrated working experience in managing laboratory operations / manpower, with domain experience in clinical lab testing environment, preferably with specialization in molecular diagnostics (7 - 10 years of experience) 
• Strong organizational skills, with demonstrated leadership qualities 
• Excellent time management and stakeholder management skills 
• Demonstrate innovative/results-oriented mentality towards problem-solving 
• Prior experience leading teams an advantage.