Global Study Lead (FSP)

Overview

The Global Study Lead is a fully client-embedded Clinical Operations representative and single accountable person who drives operational strategy, planning, and global clinical study leadership in alignment with asset strategy. The role partners with the Global Study Manager as a leadership-operational duo.

What you'll do

• 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 related functions.
• Ensure alignment between global strategy and 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 closeout.
• Ensure protocol execution is consistent globally.
• Manage external vendors and CRO partners.
• Track vendor performance metrics and service quality, resolve operational issues and escalations, and ensure vendors meet contractual obligations and timelines.
• Monitor study budgets and forecasts, track study spend against plan, identify resource gaps and operational risks, and support financial governance and change management.
• Identify study risks early and lead mitigation and contingency planning.
• Handle escalations related to recruitment delays, protocol deviations, data quality issues, 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, and sponsors or 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 that impact study delivery while balancing quality, speed, cost, and patient safety.
• Recommend process improvements and efficiencies.

What you'll need

• Bachelor’s degree in life sciences or a related discipline.
• A good understanding of complex clinical development and regulatory processes.
• At least 15+ years of relevant study management experience on a global level.
• In-depth experience in clinical research, including study management, monitoring, and data management.
• Previous in-depth Oncology experience.
• Exposure to clinical study management end-to-end globally across NA, EMEA, APAC, and LATAM.
• Proven experience from study feasibility to CSR.
• At least Ph II and PIII experience.
• Proven cross-functional leadership experience and the ability to drive internal and external meetings.
• Ability to input into clinical protocols, ICF, and other study plans.
• Clinical study risk management and clinical systems savvy.
• Strong experience in clinical budget management.
• Strong experience with vendor management, including CROs.
• Fluent in English, to the level required to negotiate and discuss complex topics with Clinical team members and vendors and present clear status to upper management when required.
• Excellent stakeholder management and communication skills, oral and written.
• Outstanding interpersonal skills.
• Leadership skills that promote motivation and empowerment of others to accomplish individual, team, and organizational objectives.
• Strong understanding of clinical study, drug development, sample management, and associated processes and quality requirements, including ICH/GCP guidelines and SOPs.
• Good project management skills, including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available.

Nice to have

• China, Japan, and Africa experience.
• Phase I and Phase IV experience.
• Exposure to competent authority inspections, including FDA, EMA, MHRA, and PMDA.
• Involvement in studies pivotal for drug file registration.

Details

• Location: Remote, India.
• Work schedule: Standard, Monday to Friday.
• The position is a fully client-embedded role dedicated to a leading bio-pharma company.