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 explicit 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 as
📌 Associate Director (Bengaluru)
🏢 GSK
📍 Bengaluru