Global Study Lead

🕒 May 27

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 55%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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

• Own 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 related functions • Align global 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 globally consistent protocol execution • Manage external vendors and CRO partners • Track vendor performance metrics and service quality • Resolve operational issues and escalations • 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 complies with 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 related discipline • At least 15+ years of relevant global study management experience • In-depth clinical research experience in 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 is an asset • 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, ICFs, study plans, clinical study risk management, and clinical systems • Strong clinical budget management experience • Strong vendor management experience, including CRO management • Experience with competent authority inspections, including FDA, EMA, MHRA, and PMDA; involvement in pivotal drug-registration studies is an asset • Fluent English, with the ability to negotiate, discuss complex topics, adapt messaging, and present clear status updates to upper management • Excellent stakeholder management and oral and written communication skills • Outstanding interpersonal skills • Leadership skills that promote motivation and empowerment • Strong understanding of clinical studies, drug development, sample management, associated processes, quality requirements, ICH/GCP guidelines, and SOPs • Good project management skills, including scope, budget, timeline, and resource planning and management, plus use of associated tools

🏖️ Benefits

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