Phase 1 Clinical Trial Manager - Cancer Trials Operations

Montefiore New Rochelle; New York (NY); Hybrid; USD 76,000 - 95,000; Full time

Job summary

Montefiore New Rochelle is seeking a Phase 1 Clinical Trial Manager to support the CCTO Phase 1 program for solid tumor trials. You will oversee daily operations and serve as the primary liaison among investigators, research staff, ancillary departments, and sponsors.

The role requires 3-5 years in clinical research, a Bachelor's degree, and preferably CCRP/CCRC certification, with strong knowledge of ICH-GCP and FDA regulations. Proactive problem solving and strong communication are essential.

Qualifications

• Bachelor's degree required; Master's preferred.
• 3-5 years experience in clinical research.
• CCRP or CCRC certification preferred.
• Knowledge of ICH-GCP, NCI, and FDA clinical trials regulations.
• Strong communication and organizational skills.

Responsibilities

• Oversee daily operations of solid tumor Phase 1 trials.
• Coordinate investigators, staff, departments, and sponsors.
• Support research billing and ensure billing compliance.
• Monitor data metrics and portfolio performance.
• Escalate operational issues proactively.

Skills

MS Office Proficiency

Communication Skills

Cross-functional Collaboration

Education

Bachelor's degree

Master's degree preferred

Tools

EDC

CTMS

Job description

Montefiore New Rochelle is seeking a Phase 1 Clinical Trial Manager to support the CCTO Phase 1 program for solid tumor trials. You will oversee daily operations and serve as the primary liaison among investigators, research staff, ancillary departments, and sponsors.

The role requires 3-5 years in clinical research, a Bachelor's degree, and preferably CCRP/CCRC certification, with strong knowledge of ICH-GCP and FDA regulations. Proactive problem solving and strong communication are essential.