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 global clinical study
Lead cross-functional study teams (clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, etc.)
Ensure alignment between general 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 when needed
7. Cross-Functional Communication
Serve as the central operational

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