Clinical Laboratory Study Manager
4 weeks ago
About the Role:
This is a key opportunity to join our team as a Clinical Laboratory Study Manager, responsible for managing key priority GSK clinical trials in oncology, infectious diseases, respiratory, immuno-inflammation, and fibrosis therapeutic areas. You will be accountable for collaboration with GSK internal and external stakeholders to deliver HBS related business objectives.
Key Responsibilities:
• Contributing to the development of study protocols, ICFs, laboratory related HBS documents, and laboratory budgets.
• Coordination of laboratories setup, including contracting and specification development.
• Driving the operational set-up to align HBS flows, testing activities, data flows, and ensuring it is in line with the other stakeholder's engagement to ensure that all study activities are operationally set-up and conducted in line with the biospecimens management approach agreed with the clinical study team.
• Comprehensive oversight of the laboratories involved, milestones achieved, and the data quality provided at the study level.
Required Qualifications:
• Master's degree in medical/life sciences.
• At least 4 years of proven operational experience in clinical trials conduct, demonstrating an excellent understanding of the clinical trials, drug development, samples management, and other associated process and quality requirements, including ICH-GCP guidelines.
• At least 2 years of proven operational experience in clinical laboratory activities.
• Strong managerial and organizational skills; ability to manage workload along with proactive issues monitoring and seeking opportunities to solve problems.
• Fluent in spoken and written English along with strong communication and presentation skills.
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
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