Senior Clinical Trial Manager, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide comprehensive operational leadership for intricate clinical trials from initiation to completion, ensuring timely delivery, adherence to budget, and compliance with global regulations and company standard operating procedures.

• Lead interdisciplinary study teams and foster alignment among Clinical Development, Regulatory, Biometrics, and external collaborators.

• Formulate and implement strategies for enrollment, site management, and monitoring to guarantee high-quality trial execution and performance.

• Supervise the performance of CROs and vendors, including KPI management, quality oversight monitoring, document review and approval, and support for vendor selection.

• Collaborate with Data Management and Medical teams to perform continuous data review and ensure prompt resolution of queries.

• Create and manage essential study documents and operational tools, such as protocols, informed consent forms, project plans, budgets, and study materials.

• Conduct study-related training for investigators, site staff, and internal teams.

• Proactively identify, evaluate, and escalate operational risks along with mitigation strategies and clear recommendations.

• Mentor and support junior clinical operations personnel, potentially including dotted-line management responsibilities.

• Travel up to 10% as needed to support study oversight and engage with sites.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related discipline with over 7 years of progressive experience in clinical trial management within biotech, pharmaceutical, and/or CRO settings.

• Proven expertise in managing clinical trials from start-up to close-out, including experience with global, multi-site studies and CRO partners.

• Required experience in oncology clinical trials; preferred experience includes solid tumor and early-phase (Phase I/Ib or II) studies.

• Extensive knowledge of ICH-GCP, FDA/EMA regulations, and global regulatory standards, with a strong emphasis on quality and readiness for inspections.

• Proficient with clinical trial systems, including CTMS, eTMF platforms, IRT systems, EDC systems, and safety databases.

• Ability to excel in a collaborative, fast-paced, growth-oriented biotech environment with shifting priorities and high accountability.

🏝️ Benefits

• Company-paid healthcare

• Flexible spending accounts

• Voluntary life insurance

• 401K matching

• Uncapped vacation