Senior Global Clinical Trial Manager – Oncology

Summit Therapeutics Inc.; Miami (FL); On-site; USD 158,000 - 185,000; Full time

Job summary

Summit Therapeutics Inc. in Miami, FL is seeking a Senior Clinical Trial Manager to provide strategic leadership and end-to-end operational oversight of complex global oncology trials.

You will manage study start-up through closeout, oversee CROs, and mentor CTMs while ensuring data quality and inspection readiness. The role requires 8–10+ years in clinical operations, extensive CTM experience in international phase II/III oncology trials, and willingness to travel up to 20% internationally.

Qualifications

• 8-10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations.
• 7+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials.
• Ability to travel internationally up to 20%.
• Proven capabilities to interpret complex scientific concepts with proficiency in reviewing, analyzing and critically assessing clinical data.
• Proven proficiency in overseeing large complex studies being managed in house and by a CRO.
• Demonstrated ability to lead teams in a fast-paced environment and to solve regulatory and timeline challenges.
• Expert knowledge of the drug development process, ICH guidelines/GCP, with understanding of all phases of clinical trial execution.

Responsibilities

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Lead and provide strategic leadership for CROs, ensuring study quality and enrollment strategies.
• Draft and approve study-related plans, CRFs, data management, and safety monitoring activities.
• Lead TMF quality reviews and ensure regulatory compliance and inspection readiness.

Skills

Clinical trial management

Regulatory knowledge

Cross-functional leadership

Travel readiness

Problem solving

Communication skills

Leadership

ICH GCP knowledge

Education

Bachelor's degree in life sciences

Job description

Summit Therapeutics Inc. in Miami, FL is seeking a Senior Clinical Trial Manager to provide strategic leadership and end-to-end operational oversight of complex global oncology trials.

You will manage study start-up through closeout, oversee CROs, and mentor CTMs while ensuring data quality and inspection readiness. The role requires 8–10+ years in clinical operations, extensive CTM experience in international phase II/III oncology trials, and willingness to travel up to 20% internationally.