Jobs / Poland / Glaxosmithkline LLC
Associate Director Global Study Lead
Glaxosmithkline LLC · 🌍 Warsaw
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About the role
The Global Study Lead will lead the planning and delivery of a global clinical study and work with cross-functional teams across clinical development, data management, safety, regulatory and external partners. We value clear decision-making, practical problem solving and a collaborative approach. This role offers visible impact, strong learning opportunities and the chance to help deliver work that advances GSK’s mission of uniting science, technology and talent to get ahead of disease together. Key Responsibilities: • Provide oversight and support to the appropriate teams on end-to-end clinical study delivery. • Serves as the point of escalation for Clinical Operations. • Ensure compliance with ICH [International Council for Harmonisation] /GCP [Good Clinical Practice] guidelines, all applicable laws and regulations, and GSK SOPs [Standard Operating Procedure] for assigned studies. understand study contribution to program/submission. • Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead • Balance risk/benefit to make decisions based on clear understanding of impact on the study and project. • As the SLT [Senior Leadership Team] escalation point for clinical operations, support the Working Groups leads to proactively and effectively identify, oversee, and mitigate study risks. • Ensure appropriate stakeholder communication, including study status, expectations, risks and issues. • Ensure robustness in upfront feasibility and planning • Preparation of materials for governance and / or financial review cycles. • Effectively build and lead empowered matrix teams. • Provide strategic oversight on operational input into protocol and informed consent form development, and other key study documents. • Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies. • Lead / contribute to ways of working and process improvement initiatives. • Leads assessment and selection of FSO [Full-Service Outsourcing] vendors in collaboration with COAL [Clinical Operations Asset Lead] and be an escalation point for vendor issues. • Ambassadors in increasing utilisation of AIML [Artificial Intelligence & Machine Learning] tools, driving automation of manual processes, finding efficiencies and more effective ways of working. Basic Qualifications: • Bachelor's degree in life sciences, pharmacy, nursing, or related field. • Minimum 5 years’ experience in clinical operations or study management within pharmaceutical industry or CRO [Contract Research Organization]. • Experience in leading global study set-up and delivery with multi-country execution. • Experience with ICH/GCP and applying global regulatory and safety requirements along with stakeholder management • Experience in project planning, risk management and standard clinical trial systems or tools. • Experience in delivering verbal and written communication in English language. Preferred Qualifications: • Advanced degree in life sciences, clinical research, or in these related field. • Experience with complex or adaptive study designs and/or real-world evidence studies. • Experience managing outsourced vendors and CRO oversight. • Experience with implementing process improvements or efficiencies in study delivery. • Experience with electronic data capture, data management oversight or medical review activities. • Experience working in cross-functional matrix teams. • Previous secondment experience or history of working in temporary global assignments. Work Arrangement: This role offers a hybrid working model, with a mix of on-site and remote work. Why GSK? • Career at one of the leading global healthcare companies. • Contract of employment