Senior Clinical Trial Manager, Clinical Operations (EU)

📋 Description

• • Iambic Therapeutics, Inc. is seeking a highly motivated and experienced Senior Clinical Trial Manager (CTM) to join our dynamic Clinical Operations team. This pivotal role will serve as the operational leader for early-phase oncology clinical trials, guiding them through the entire lifecycle from initial start-up to final close-out. You will be instrumental in ensuring the successful execution of these critical studies, working collaboratively with internal departments such as Clinical Development, Regulatory Affairs, and Biometrics, as well as external partners like Contract Research Organizations (CROs).
• • As the Senior CTM, you will be responsible for driving high-quality, inspection-ready clinical trial execution within a fast-paced, growth-stage biotech environment. Your primary focus will be on international regions, including Europe, Asia-Pacific, and the United Kingdom, with secondary oversight responsibilities for North America. This position reports directly to the Director of Clinical Operations and offers the flexibility of remote work within the EU or UK.
• • You will provide comprehensive end-to-end operational leadership for complex, multi-regional clinical trials. This includes ensuring that all studies are delivered on time, within budget, and in strict adherence to global regulatory requirements and internal Standard Operating Procedures (SOPs). Your leadership will be crucial in navigating the intricacies of early-phase oncology research.
• • A key aspect of this role involves leading cross-functional study teams, fostering strong collaboration and driving alignment across all involved departments and external partners. You will be the central point of contact, ensuring seamless communication and coordinated efforts towards common study goals.
• • You will be tasked with developing and executing robust enrollment, site management, and monitoring strategies. These strategies are designed to guarantee the highest standards of clinical trial conduct and performance, ensuring data integrity and patient safety.
• • A significant responsibility will be the meticulous oversight of CROs and other vendors. This includes managing Key Performance Indicators (KPIs), ensuring quality oversight in monitoring activities, reviewing and approving essential documents, and actively participating in vendor selection processes. Your ability to manage these external relationships effectively will be paramount.
• • You will partner closely with the Data Management and Medical Affairs teams to conduct ongoing data reviews. This collaboration is essential for ensuring timely query resolution, maintaining data accuracy, and supporting the overall integrity of the trial results.
• • The role requires the development and management of critical study documents and operational tools. This encompasses a range of essential materials, including clinical trial protocols, informed consent forms, detailed project plans, study budgets, and various study-related materials, ensuring all documentation is accurate, compliant, and up-to-date.
• • You will lead comprehensive study-related training initiatives for investigators, site personnel, and internal teams. Effective training is vital for ensuring consistent understanding and application of study procedures and regulatory requirements.
• • Proactive risk management is a core function. You will be expected to identify, assess, and escalate operational risks, developing and implementing effective mitigation strategies and providing clear, actionable recommendations to address potential challenges.
• • This position offers an opportunity to mentor and support junior clinical operations staff. You may also have dotted-line management responsibilities, contributing to the growth and development of the clinical operations team.
• • The role requires a commitment to travel, estimated at 10–20%, to support regional study oversight and engage directly with clinical trial sites, fostering strong site relationships and ensuring operational excellence on the ground.