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 general 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 activi

📌 Global Sr Project Manager (Bogotá)
🏢 Thermo Fisher Scientific
📍 Bogotá