Remote Senior Clinical Trial Leader - Oncology Programs

Menarini Group; New York (NY); On-site; USD 192,000 - 206,000; Full time

Job summary

Menarini Stemline is seeking a Senior Clinical Trial Manager to develop operational strategy and lead day‑to‑day study execution in a remote US setting. You will steer a cross-functional Clinical Trial Team, manage CRO/vendors, and ensure timelines, budget, quality, and regulatory adherence across oncology studies.

Ideal candidates have 8+ years in clinical research, oncology experience, and strong ICH/GCP/FDA CFR knowledge, with excellent communication and leadership skills for matrix

Qualifications

• BA/BS degree required; advanced degree preferred.
• At least 8 years of clinical research experience with sponsor or CRO.
• Oncology experience required.
• Understanding of clinical development in Phase I–III.
• Strong knowledge of ICH/GCP and FDA CFR.
• Excellent written and verbal communication.

Responsibilities

• Lead start-up activities including site feasibility and regulatory pack preparation.
• Develop study documents such as protocol, CRFs, and study tools.
• Oversee CRO/vendor selection and management to meet quality standards.
• Serve as primary contact for site-related issues.
• Lead the global cross-functional Clinical Trial Team and chair sub-teams.
• Define Data Review Plan and ensure data quality and cleanliness.
• Manage trial budgets and forecasting with CTL/Program Lead.
• Coordinate trial advisory committees and governance.
• Ensure eTMF is maintained and audit-ready.
• Contribute to process improvements and QA inspections.
• Mentor Clinical Trial Managers and Assistants.

Skills

Clinical trial management

Oncology experience

ICH/GCP knowledge

FDA CFR knowledge

Communication

Project management

Cross-functional collaboration

Education

BA/BS degree or equivalent

Advanced degree preferred

Job description

Menarini Stemline is seeking a Senior Clinical Trial Manager to develop operational strategy and lead day‑to‑day study execution in a remote US setting. You will steer a cross-functional Clinical Trial Team, manage CRO/vendors, and ensure timelines, budget, quality, and regulatory adherence across oncology studies.

Ideal candidates have 8+ years in clinical research, oncology experience, and strong ICH/GCP/FDA CFR knowledge, with excellent communication and leadership skills for matrix