Clinical Trial Manager - Remote

Overview

The Clinical Trial Manager in the Research Alliances team will oversee the planning, execution, management, and reporting of clinical projects supporting Iovance commercial activities, including Expanded Access Programs (intermediate EAP, single-patient and Ex-US Named Patient Programs) and Phase 4 post marketing pharmacovigilance studies. In addition, the Clinical Trial Manager will support a growing portfolio of Investigator Sponsored collaborations and other non-clinical collaborative research initiatives involving lifileucel and Proleukin. This position works very closely with external vendors, HCPs, as well as multiple Iovance teams: Commercial, Medical Affairs, Regulatory, Safety, Clinical, Biometrics, Quality, Legal, Quality, Supply Chain & Logistics and Manufacturing.

In Short

• Oversee planning and execution of clinical projects.
• Manage Expanded Access Programs and post-marketing studies.
• Collaborate with external vendors and healthcare professionals.
• Ensure compliance with regulatory requirements.
• Track and report study progress and performance.
• Manage relationships with investigative sites.
• Prepare and maintain essential regulatory documents.
• Lead process improvements and SOP updates.
• Perform miscellaneous duties as assigned.
• Travel required: 20% of the time.

Requirements

• Bachelor’s degree in health or science-related area.
• 5+ years of clinical operations experience.
• Experience managing EAPs and clinical trials.
• Excellent interpersonal and communication skills.
• Knowledge of US and Global Regulations (ICH-GCP, FDA-CFR).
• Experience with data collection and monitoring.
• Proficient in Microsoft Office and EDC systems.
• Strong organizational and multitasking abilities.

Benefits

• Diverse and inclusive work environment.
• Equal opportunity employer.
• Support for reasonable accommodations.