Senior Clinical Trial Manager, Clinical Operations

📋 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 their entire lifecycle from initial start-up activities to final close-out.
• • As the Senior CTM, you will be instrumental in ensuring the successful execution of complex clinical studies. This involves close collaboration with internal departments such as Clinical Development, Regulatory Affairs, Biometrics, and Data Management, as well as external partners including Contract Research Organizations (CROs) and other vendors.
• • Your primary responsibility will be to drive high-quality, inspection-ready trial conduct, adhering strictly to global regulatory requirements, ICH-GCP guidelines, and Iambic's Standard Operating Procedures (SOPs). This role demands a proactive approach to managing all operational aspects of clinical trials, ensuring they are delivered efficiently, on time, and within budget.
• • You will lead and foster alignment within cross-functional study teams, facilitating effective communication and decision-making to achieve study objectives. This includes developing and implementing robust enrollment strategies, site management plans, and monitoring strategies designed to guarantee the highest standards of trial conduct and performance.
• • A significant part of your role will involve the meticulous oversight of CROs and other vendors. This includes defining Key Performance Indicators (KPIs), monitoring their quality and performance, reviewing and approving critical documents, and actively participating in vendor selection processes to ensure we partner with the best-in-class service providers.
• • You will work closely with Data Management and Medical teams to conduct ongoing reviews of clinical trial data, ensuring data integrity and facilitating timely query resolution to maintain the quality and completeness of the study database.
• • The Senior CTM will be responsible for the development and management of essential study documents and operational tools. This encompasses a wide range of materials, including clinical trial protocols, informed consent forms (ICFs), comprehensive project plans, detailed budgets, and various study-related materials required for effective trial execution.
• • You will play a key role in educating and training investigators, site personnel, and internal teams on study-specific procedures, protocols, and regulatory requirements, ensuring a consistent understanding and application of study conduct standards.
• • Proactive risk management is a critical component of this position. You will be expected to identify, assess, and escalate operational risks, developing and implementing effective mitigation strategies and providing clear, actionable recommendations to leadership.
• • This role offers an opportunity for leadership development, including mentoring and supporting junior clinical operations staff. Depending on the team's structure, you may also have potential dotted-line management responsibilities, contributing to the growth and development of the clinical operations team.
• • Travel, up to 10%, may be required to support study oversight activities, engage with clinical sites, and attend relevant meetings, ensuring a hands-on approach to trial management.
• • This position reports directly to the Director of Clinical Operations and is based at our San Diego Headquarters, offering a chance to contribute to a cutting-edge, growth-stage biotech company at the forefront of AI-driven drug discovery.
• • You will be an integral part of a mission-driven organization focused on delivering better medicines through innovation, working within a culture that values diversity, inclusion, and collaboration.