Global Study Lead – FSP

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🕒 May 27

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Overall Study Leadership • Own the day-to-day management of the global clinical study. • Lead cross-functional study teams (clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, etc.). • Ensure alignment between global strategy and regional execution. • Drive study timelines, milestones, and deliverables. • Develop and maintain: study timelines operational plans risk management plans enrollment strategies. • Oversee country start-up, site activation, recruitment, monitoring, and closeout. • Ensure protocol execution is consistent globally. • Manage external vendors and CRO partners. • Track performance metrics and service quality. • Resolve operational issues and escalations. • Monitor study budgets and forecasts. • Identify resource gaps and operational risks. • Support financial governance and change management. • Identify study risks early. • Lead mitigation and contingency planning. • Ensure study conduct follows: ICH-GCP local regulations SOPs protocol requirements. • Serve as the central operational contact for the study. • Communicate updates to senior leadership, study teams, regional teams, sponsors/partners. • Monitor enrollment, data cleaning, query resolution, and database lock readiness. • Ensure timely delivery of quality data. • Make operational decisions that impact study delivery. • Recommend process improvements and efficiencies.

🎯 Requirements

• Bachelor’s degree: life sciences or related discipline; • At least 15+ years of relevant study management experience on a global level. • In-depth experience in clinical research: study management, monitoring, data management. • Previous in-depth Oncology experience. • Must have exposed to clinical study management “end-to-end” Globally: NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset. • Must have proven experience from study feasibility to CSR. • Must have at least Ph II and PIII experience – PI & PIV is an asset. • Must have cross-functional leadership proven experience, able to drive internal and external meeting. • Strong experience in clinical budget management. • Strong experience with vendor management including CRO. • Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an asset. • Fluent in English to the level they can negotiate and discuss (adapt message) related to complex topics with any Clinical team member. • Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.

🏖️ Benefits

• Health insurance • 401(k) matching