Global Study Lead (FSP)

Job Title: Global Study Lead (FSP) Job Location: Remote, India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Global Study Lead – This position is a fully client-embedded role, dedicated to a leading bio-pharma company.

Role Purpose: This GSL is a single accountable person and a Clinical Operations representative. Will drive operational strategy, planning and leading the study and being aligned with the asset strategy. The GSL and GSM work s a leadership-operational duo.

Key Responsibilities

1. Overall Study Leadership Own the day-to-day management of the global clinical study Lead cross-functional study teams (clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, etc.)

Ensure alignment between global strategy and regional execution Drive study timelines, milestones, and deliverables 2.

Study Planning and Execution Develop and maintain: study timelines operational plans risk management plans enrollment strategies Oversee country start-up, site activation, recruitment, monitoring, and closeout Ensure protocol execution is consistent globally 3.

Vendor and CRO Oversight Manage external vendors and CRO partners Track performance metrics and service quality Resolve operational issues and escalations Ensure vendors meet contractual obligations and timelines 4.

Budget and Resource Management Monitor study budgets and forecasts Track study spend against plan Identify resource gaps and operational risks Support financial governance and change management 5.

Risk and Issue Management Identify study risks early Lead mitigation and contingency planning Handle escalations related to: recruitment delays protocol deviations data quality issues supply shortages inspection readiness 6.

Regulatory and Quality Compliance Ensure study conduct follows: ICH-GCP local regulations SOPs protocol requirements Support inspection re