Global Study Lead - FSP Team
Work Schedule
Standard (Mon-Fri) Environmental Conditions
Office Job Description
Job Title: Global Study Lead (GSL) Department: Global Clinical Study Delivery (GCSD), Global Clinical Operations
Job Purpose:
This position within GCSD is accountable for leading the operational strategy, planning and delivery of the study/studies end to end from CSI (Commit to Study Initiation) until study archiving to time, quality, budget, company standards and scientific requirements as outlined in the clinical development plan. The GSL owns the vision for study success, the prioritization of deliverables and formation of Working Groups with key leadership across the matrix organization with the Study Level Statistician and Clinical Lead. The GSL represents Clinical Operations within the Study Leadership Team (SLT).
Key responsibilities include, but are not limited to:
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GSL will be a member of the Study Leadership Team (SLT) with accountability for the strategic leadership and delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, driving decision making at pace and strategically leading study team to achieve overall study deliverables.
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Provide oversight and support (where needed) to the GSM and SM (as appropriate) on end-to-end clinical study delivery. Serves as the point of escalation for Clinical Operations.
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Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies. understand study contribution to program/submission
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Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead.
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Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.
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As the SLT escalation point for clinical operations, support the Working Groups leads to proactively and effectively identify, oversee, and mitigate study risks.
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Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.
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Ensure robustness in upfront feasibility and planning.
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Preparation of materials for governance and / or financial review cycles.
- Accountable for the study budget.
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Effectively build and lead empowered matrix teams.
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Implement innovative approaches to study delivery through external facing advances in technology and sciences and encourage others within matrix and line teams to seek innovative perspectives and develop solutions in collaboration with the GSM and SM.
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Decision maker for the innovative solutions (e.g. DCT) to be used at study level.
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Provide strategic oversight on operational input into protocol and informed consent form development, and other key study documents.
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Ambassadors in increasing utilisation of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working.
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Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
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Lead / contribute to ways of working and process improvement initiatives.
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Provides therapeutic area expertise to support operations.
- Escalation point for vendor issues.
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Leads assessment and selection of FSO vendors in collaboration with COAL.
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Accountable for holistic oversight of FSO vendors according to the FSO handbook in collaboration with GSM and SM.
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Accountable for assessment and selection of other study vendors under GCSD responsibility in collaboration with GSM and SM.
Education Requirements (minimum expected):
Bachelor’s degree: life sciences or related discipline The role will require a good understanding of complex clinical development and regulatory processes.
Job Related Experience (minimum requirements):
Highly experienced strategic leader capable of performing study accountable role in an autonomous way across multiple studies or a single large / complex study. Has depth and breadth of experie