Senior Clinical Trial Operations Leader

Summit Therapeutics Inc.; Miami, Northern (FL, KY); Hybrid; USD 117,000 - 137,000; Full time

Benefits offered by this job

Pay transparency

Job summary

Summit Therapeutics Inc. is seeking a Senior Clinical Trial Associate to support daily clinical operations in Miami, onsite. You will provide robust administrative support to study teams, manage meeting logistics, agendas, and minutes, and assist with budget forecasting and tracking.

The ideal candidate has a 4+ year background in clinical studies, CTMS/eTMF experience, and strong regulatory knowledge, enabling cross-functional collaboration and meticulous documentation.

Qualifications

• Bachelor’s degree in biological sciences or health sciences and 4+ years of clinical study experience.
• Experience with CTMS and eTMF systems in CRO or pharmaceutical settings.
• Strong knowledge of FDA regulations, GCP, and ICH guidelines.

Responsibilities

• Provide comprehensive administrative support to the clinical operations study team.
• Manage meeting logistics, agendas, and minutes with oversight.
• Assist in study budget forecasting and tracking.
• Ensure eTMF and study documents are compliant and filed.
• Coordinate contract management and vendor oversight across teams.
• Support cross-functional teams to maintain study milestones and CTMS/EDC data.

Skills

CTMS

eTMF

Regulatory compliance

ICH guidelines

Project coordination

Interpersonal communication

Education

Bachelor's degree in biological sciences

4+ years clinical study experience

Tools

CTMS

eTMF Tools

Job description

Summit Therapeutics Inc. is seeking a Senior Clinical Trial Associate to support daily clinical operations in Miami, onsite. You will provide robust administrative support to study teams, manage meeting logistics, agendas, and minutes, and assist with budget forecasting and tracking.

The ideal candidate has a 4+ year background in clinical studies, CTMS/eTMF experience, and strong regulatory knowledge, enabling cross-functional collaboration and meticulous documentation.