Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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 integral 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 readiness and audit activities
- Oversee CAPAs whe

📌 Global Study Lead (Colombia)
🏢 Thermo Fisher Scientific
📍 Colombia