Clinical Laboratory Study Manager

4 tygodni temu

Warszawa, Mazovia, Polska MyGwork Pełny etat
Job Title: Clinical Laboratory Study Manager

This role involves managing key priority GSK clinical trials in oncology, infectious diseases, respiratory, immuno-inflammation, and fibrosis therapeutic areas. The successful candidate will be responsible for the central management of samples collection and testing, as well as collaboration with internal and external stakeholders to deliver Human Biological Samples Management (HBS) related business objectives.



Key Responsibilities:

• Contributing to the development of study protocols, ICFs, laboratory-related HBS documents, and laboratory budgets
• Coordination of laboratory setup (central and niche), including contracting and specification development
• Driving operational setup to align HBS flows, testing activities, data flows, and ensuring it is in line with other stakeholders' 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
• Consulting on laboratory and clinical diagnostic-related issues, being the laboratory subject matter expert and HBS custodian to review results, service quality, and contribute to the development of new processes and agile management

Requirements:

• Master's degree in medical/life sciences
• At least 4 years of proven operational experience in clinical trials conduct, demonstrating an excellent understanding of 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 (preferred for CLSM role)
• Strong managerial and organizational skills; ability to manage workload, along with proactive issues monitoring and seeks opportunities to solve problems
• Fluency in spoken and written English, along with strong communication and presentation skills

Why GSK?

At GSK, we offer a wide range of benefits, including career opportunities, hybrid work, a contract of employment, an attractive reward package, life insurance, a pension plan, private medical package, sports cards, and opportunities for development within the role and company's structure. We want to hear from you and support with any adjustments that you may require during the recruitment process.

About GSK:

GSK is a global biopharma company that unites 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 (infectious diseases, HIV, respiratory/immunology, and oncology). We want GSK to be a place where people can thrive, feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves, feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.

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