Global Study Lead – FSP

Job not on LinkedIn

🕒 6 days ago

🇨🇴 Colombia – Remote

⏰ Full Time

🟠 Senior

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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: Manage global clinical study and cross-functional study teams • Study Planning and Execution: Develop timelines and operational plans, oversee country start-up and closeout • Vendor and CRO Oversight: Manage external vendors, track performance metrics, resolve operational issues • Budget and Resource Management: Monitor study budgets and forecasts • Risk and Issue Management: Identify early risks, lead mitigation planning • Regulatory and Quality Compliance: Ensure compliance with ICH-GCP and local regulations • Cross-Functional Communication: Central operational contact, communicate updates to teams • Data and Study Oversight: Monitor enrollment, data quality, and ensure timely delivery of quality data • Strategic Decision-Making: Make operational decisions impacting study delivery

🎯 Requirements

• Bachelor’s degree: life sciences or related discipline • At least 6+ 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 • Experience from study feasibility to CSR • Proven experience from Ph II and PIII studies • Fluency in English to negotiate and discuss complex topics • Excellent stakeholder management and communication skills • Strong understanding of clinical study, drug development, sample management, and other associated processes • Good project management skills with associated tools

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development

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