Global Study Lead – FSP Team

Job not on LinkedIn

🕒 June 5

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

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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

• Lead the operational strategy, planning and delivery of the study/studies end to end from CSI (Commit to Study Initiation) until study archiving. • Provide oversight and support to the GSM and SM on end-to-end clinical study delivery. • Ensure compliance with ICH/GCP guidelines. • 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. • Ensure appropriate stakeholder communication, including study status, expectations, risks and issues. • Effectively build and lead empowered matrix teams. • Implement innovative approaches to study delivery through advances in technology and sciences. • Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.

🎯 Requirements

• Bachelor’s degree: life sciences or related discipline • Highly experienced strategic leader capable of performing study accountable role in an autonomous way across multiple studies or a single large / complex study. • Extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment. • Proven operational experience of leading high performing global study teams in clinical trials. • In-depth knowledge of study management and knowledge of essential global regulatory guidelines and ICH/GCP. • Excellent project management skills and budget management skills.

🏖️ Benefits

• Health insurance • Professional development opportunities • Paid time off