Clinical Trial Manager (CTM)

Apply Job Type Full-time Description Summary: We are seeking an experienced and results-driven Clinical Trial Manager to join our team at Kumquat Biosciences. As a Clinical Trial Manager, you will play a pivotal role in planning, executing, and overseeing oncology clinical trials. You will be responsible for managing cross-functional teams, ensuring study milestones are met, and that trials are conducted in compliance with regulatory guidelines and company protocols. Key Responsibilities: Perform the day-to-day management of early phase clinical trials or support the study lead(s) on one or more complex global clinical trials. Develop and execute clinical trial plans, including study timelines, budgets, and resource allocation. Manage trial budgets, contracts, and vendor relationships. Collaborate with investigators, clinical sites, and key opinion leaders to ensure successful trial execution. Ensure the timely initiation, monitoring, and close-out of clinical trial sites, including the selection of qualified investigative sites. Oversee patient recruitment and retention strategies, ensuring trial objectives are met. Oversee vendors and investigative sites in the collection and management of clinical data to fulfill study objectives. Proactively identify and mitigate risks and challenges throughout the course of the trial. Ensure strict compliance with Good Clinical Practice (GCP) guidelines and relevant regulations. Prepare for and manage audits and inspections by regulatory authorities. Requirements Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience. 6+ years of clinical operations experience or related drug development with 2+ years at a sponsor company. Vendor/clinical service provider management experience required. In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research. Strong clinical study execution, leadership, and project management skills required. Demonstrated experience in data cleaning and management to support study objectives and data deliverables. Excellent communication, collaboration, and problem-solving abilities. Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems. Willingness to travel to investigational sites as required. Familiarity with early phase clinical trial protocols and procedures a plus. Salary Description: $140k-$155k Salary Description $140K-$155K