Clinical Trial Manager

Role Overview

We are seeking an experienced Clinical Trial Manager to provide both strategic leadership and hands-on oversight of early-stage oncology trials, including first-in-human trials. Reporting to the Director of Clinical Operations, you will oversee all aspects of trial management -from start-up through close-out - ensuring trials are delivered on time, on budget, and fully compliant with regulatory and quality standards. As the primary point of contact for cross-functional teams, CROs, vendors, and investigative sites, you will provide strategic guidance, operational oversight, and proactive risk management. This is a hands-on role in a fast-paced, collaborative environment, offering the opportunity to directly influence the advancement of innovative therapies for patients.

Key Responsibilities

• Work with a cross-functional trial teams to manage all aspects of clinical trials ensuring trials are executed on time, on budget, and in compliance with SOPs, ICH/GCP, and regulatory requirements.
• Identify and anticipate trial issues or risks that may impact budget, resources, and timelines; plan mitigation strategies with the cross-functional team and escalates as necessary.
• Manage outsourced activities with CROs and vendors (e.g., biomarker and specialty labs), including oversight of performance, compliance with ICH/GCP and SOPs, development of oversight plans, and review of monitoring reports to maintain trial quality and compliance.
• Manage trial budgets and contracts, including forecasting, invoice review, and expense tracking for accurate reporting.
• Monitor trial progress, including participant enrollment, clinical data review, sample collection, and adherence to timelines; provide regular trial status updates and metrics.
• Guide trial teams and investigator sites to ensure consistent interpretation and execution of trial protocols and procedures.
• Contribute to the development and review of trial-related documents (protocols, ICFs, clinical trial plans, CRFs, manuals, reports, and regulatory documentation).
• Ensure Trial Master File (TMF) completeness, accuracy, and inspection readiness, whether managed internally or outsourced.
• Participate in the development and refinement of departmental SOPs, processes, and best practices.

Qualifications/Experience

• Bachelor’s degree in Life Sciences or related field (advanced degree preferred) with 3+ years of clinical trial management experience.
• Proven track record in CRO and vendor management, including oversight of performance, issue resolution, and budget management.
• Ability to lead trials independently, ideally within a small, fast-paced team environment.
• Working knowledge of data management, biostatistics, and pharmacovigilance.
• Global trial experience, including management of multi-country trials from start-up through close-out.
• Thorough understanding of FDA regulations and ICH GCP guidelines.
• Proficiency with clinical trial systems (EDC, CTMS, TMF) and expertise in trial master file organization and regulatory documentation.
• On-site monitoring experience (preferred).
• Excellent communication skills, with the ability to collaborate effectively across teams.
• Highly organized with strong problem-solving, critical thinking, and prioritization skills.
• Ability to travel domestically and internationally, up to 20%.