Our client is looking for a Senior Clinical Trial Manager who will serve as the operational lead for assigned early-phase oncology studies, providing end-to-end trial leadership from start-up through close-out. In close partnership with Clinical Development, Regulatory, Biometrics, and external CROs, this role drives high-quality, inspection-ready trial execution within a collaborative, growth-stage biotech environment.

This Senior CTM will be accountable for vendor oversight, risk management, timeline and budget performance, and cross-functional alignment to ensure studies are delivered efficiently and in compliance with global regulatory requirements, ICH-GCP, and company SOPs. This position reports to the Director of Clinical Operations and is fully remote.

KEY RESPONSIBILITIES

• Provide end-to-end operational leadership for complex clinical trials from start-up through close-out, ensuring delivery on time, within budget, and in compliance with global regulations and company SOPs
• Lead cross-functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners
• Develop and execute enrollment, site management, and monitoring strategies to ensure high-quality trial conduct and performance
• Oversee CRO and vendor performance, including KPI management, monitoring quality oversight, document review and approval, and vendor selection support
• Partner with Data Management and Medical to conduct ongoing data review and ensure timely query resolution
• Develop and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials.
• Lead study-related training for investigators, site personnel, and internal teams.
• Proactively identify, assess, and escalate operational risks with mitigation strategies and clear recommendations.
• Mentor and support junior clinical operations staff, including potential dotted-line management responsibilities.
• Travel up to 10% as required to support study oversight and site engagement

QUALIFICATIONS

• Bachelor’s degree in life sciences or related field with 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, and/or CRO environments
• Demonstrated expertise managing clinical trials from start-up through close-out, with experience overseeing global, multi-site studies and CRO partners
• Experience in oncology clinical trials required; solid tumor and early-phase (Phase I/Ib or II) experience preferred
• In-depth knowledge of ICH-GCP, FDA/EMA regulations, and global regulatory requirements, with a strong focus on quality and inspection readiness
• Proficiency with clinical trial systems, including CTMS, eTMF platforms, IRT systems, EDC systems, and safety databases
• Ability to thrive in a collaborative, fast-paced, growth-stage biotech environment with evolving priorities and high accountability