Clinical Trial Manager

The role

The Clinical Trial Manager manages the operational execution of clinical studies from initial synopsis through final deliverables. This role involves managing budgets, timelines, resources, and vendors for clinical programs leading to BLA submissions.

What you will do

• Support the overall operational execution of clinical studies from initial study synopsis through final project deliverables
• Manage implementation, on-time execution, and conduct of clinical studies
• Develop budget items, milestones, and timelines
• Manage scope and resources including vendor selection
• Oversee cross-functional study team members
• Perform risk management and mitigation
• Lead vendor identification, qualification, selection, and systems management
• Support and deliver trial endgame data and statistical analyses
• Critically assess data to detect trends and outliers
• Supervise multifunctional vendor groups including clinical operations, data management and biometrics

Required qualifications

• Bachelor’s degree
• 5+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience
• At least 1 year as CTM
• Demonstrated experience in core and technical aspects of designing, initiating and managing phase 1-4 clinical trials
• Demonstrated experience in management of CROs, in vendor selection
• Excellent interpersonal and communication skills
• Demonstrated leadership attributes
• Subject matter expert in application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards)
• Broad scope experience in data collection, monitoring, cleaning and analysis throughout clinical development (Phase 1-4)
• Ability to remain in a stationary position standing or sitting for prolonged periods of time
• Ability to move about inside an office and exert up to 10 pounds of force occasionally
• Visual acuity to prepare and analyze data and figures, view a computer screen, and extensive reading

About the company

Iovance Biotherapeutics, Inc. is a global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. The company operates as an end-to-end cell therapy company with centralized U.S.-based manufacturing.