Global Study Lead – FSP

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Overall Study Leadership: Oversee global clinical studies and lead cross-functional study teams.

• Study Planning and Execution: Create timelines and operational plans, and supervise country start-up and closeout phases.

• Vendor and CRO Oversight: Manage external vendors, monitor performance metrics, and resolve operational challenges.

• Budget and Resource Management: Track study budgets and forecasts efficiently.

• Risk and Issue Management: Proactively identify risks and spearhead mitigation strategies.

• Regulatory and Quality Compliance: Guarantee adherence to ICH-GCP standards and local regulations.

• Cross-Functional Communication: Act as the central operational contact, relaying updates to various teams.

• Data and Study Oversight: Oversee enrollment, data quality, and ensure timely provision of high-quality data.

• Strategic Decision-Making: Make operational decisions that significantly influence study delivery.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field.

• Minimum of 6+ years of relevant study management experience at a global level.

• Extensive experience in clinical research, including study management, monitoring, and data management.

• Prior in-depth experience in Oncology.

• Familiarity with the study process from feasibility through to Clinical Study Report (CSR).

• Proven experience with Phase II and Phase III clinical studies.

• Proficiency in English for negotiating and discussing complex topics.

• Outstanding stakeholder management and communication abilities.

• Strong comprehension of clinical studies, drug development, sample management, and related processes.

• Effective project management skills and familiarity with associated tools.

🏝️ Benefits

• Health insurance coverage.

• Flexible work arrangements available.

• Opportunities for professional development.