Global Study Lead - FSP Team
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Global Study Lead to oversee end-to-end clinical study delivery within the Global Clinical Study Delivery team. The role requires strategic leadership of study operations from initiation through archiving, with accountability for timelines, quality, budget, and regulatory compliance across complex, multi-site trials.
Responsibilities
- Lead Study Leadership Team as clinical operations representative; drive strategic study delivery to time, quality, and budget
- Oversee end-to-end study operations including GSM and SM support; serve as escalation point for clinical operations issues
- Manage study budget, vendor selection, and FSO oversight in collaboration with stakeholders
- Identify, mitigate, and escalate study risks; ensure protocol compliance and inspection readiness
- Champion innovative technologies and process improvements including DCT and AI/ML tools for operational efficiency
Requirements
- Bachelor's degree in life sciences or related discipline
- Extensive clinical development experience in pharmaceutical industry or CRO
- Proven track record leading global study teams in complex trials
- Deep knowledge of ICH/GCP guidelines and regulatory processes
- Demonstrated ability to influence senior-level stakeholders
- Experience managing study budgets and vendor oversight
- Matrix leadership capability in autonomous, high-pressure environments
Vacancy posted 11 days ago
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