Global Study Lead

🔥 3 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Own the day-to-day management of the global clinical study • Lead cross-functional study teams across clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, and other functions • Align global study strategy with regional execution • Drive study timelines, milestones, and deliverables • Develop and maintain study timelines, operational plans, risk management plans, and enrollment strategies • Oversee country start-up, site activation, recruitment, monitoring, and study closeout • Ensure consistent global protocol execution • Manage external vendors and CRO partners • Track vendor performance metrics and service quality • Resolve operational issues and escalations and ensure contractual and timeline compliance • Monitor study budgets and forecasts and track spend against plan • Identify resource gaps and operational risks • Support financial governance and change management • Identify study risks and lead mitigation and contingency planning • Handle escalations involving recruitment delays, protocol deviations, data quality, supply shortages, and inspection readiness • Ensure study conduct follows ICH-GCP, local regulations, SOPs, and protocol requirements • Support inspection readiness and audit activities and oversee CAPAs when needed • Serve as the central operational contact for the study • Communicate updates to senior leadership, study teams, regional teams, sponsors, and partners • Lead governance meetings and study reviews • Monitor enrollment, data cleaning, query resolution, and database-lock readiness • Review KPIs and operational metrics and ensure timely delivery of quality data • Make operational decisions affecting study delivery while balancing quality, speed, cost, and patient safety • Recommend process improvements and efficiencies

🎯 Requirements

• Bachelor’s degree in life sciences or a related discipline • At least 15+ years of relevant global study management experience • In-depth clinical research experience, including study management, monitoring, and data management • Previous in-depth oncology experience • End-to-end global clinical study management experience across NA, EMEA, APAC, LATAM, China, and Japan; Africa experience is an asset • Proven experience from study feasibility through Clinical Study Report (CSR) • At least Phase II and Phase III experience; Phase I and Phase IV experience is an asset • Proven cross-functional leadership experience • Ability to contribute to clinical protocols, informed consent forms (ICFs), and other study plans • Expertise in clinical study risk management and clinical systems • Strong clinical budget management experience • Strong vendor management experience, including CROs • Experience with competent authority inspections, including FDA, EMA, MHRA, and PMDA; involvement in pivotal drug-registration studies is an asset • Fluency in English sufficient to negotiate, discuss complex clinical topics, adapt messaging, and present clear status updates to upper management • Excellent stakeholder management and oral and written communication skills • Outstanding interpersonal skills • Demonstrated leadership skills, including motivating and empowering others • Strong understanding of clinical studies, drug development, sample management, associated processes, quality requirements, ICH/GCP guidelines, and SOPs • Good project management skills covering scope, budget, timelines, resources, and associated tools

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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