Global Senior Project Manager – FSP

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

📋 Description

• Take charge of the daily oversight of the global clinical study.

• Lead interdisciplinary study teams encompassing clinical operations, data management, biostatistics, medical monitoring, regulatory affairs, supply chain, safety, and more.

• Ensure coherence between global strategy and regional implementation.

• Propel study timelines, milestones, and deliverables.

• Create and uphold study timelines, operational plans, risk management strategies, and enrollment tactics.

• Supervise country start-up, site activation, recruitment, monitoring, and study closeout.

• Manage external vendors and contract research organization (CRO) partners.

• Oversee study budgets and financial forecasts.

• Proactively identify study risks at an early stage.

• Ensure that study procedures comply with ICH-GCP, local regulations, SOPs, and protocol requirements.

• Relay updates to senior leadership, study teams, regional teams, and sponsors/partners.

• Track enrollment, data cleaning, query resolution, and database lock readiness.

• Make operational decisions that influence study delivery.

⛳️ Requirements

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

• A minimum of 6+ years of relevant study management experience at a global scale.

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

• Prior extensive experience in Oncology.

• Must have been involved in clinical study management from start to finish.

• Proven experience from study feasibility to clinical study report (CSR).

• Must possess experience with Phase II and Phase III studies.

• Demonstrated cross-functional leadership experience is essential.

• Capable of contributing to clinical protocols, informed consent forms (ICF), and other study planning documents.

• Strong expertise in managing clinical budgets.

• Significant experience with vendor management, including CROs.

• Familiarity with competent authority inspections (FDA, EMA, MHRA, PMDA).

• Proficient in English, capable of negotiating and discussing complex topics with any clinical team member.

• Exceptional stakeholder management and communication skills, both oral and written.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible working hours.

• Paid time off.

• Remote work options.