Clinical Trial Manager

Clinical Trial ManagerSouth San Francisco, California, United StatesSummaryThis is an opportunity to join a science-driven organization focused on advancing precision medicine for patients with both common and rare diseases. The Clinical Trial Manager (CTM) will play a key, hands-on role in supporting the execution of clinical programs in Chronic Kidney Disease (CKD).In this position, you will contribute to mid- to late-stage clinical studies, working cross-functionally with internal stakeholders and external partners to ensure studies are executed efficiently, on time, and in compliance with quality and regulatory standards. This role is well-suited for someone who enjoys being deeply involved in trial execution, collaborating across functions, and helping bring innovative therapies to patients.Key ResponsibilitiesLead or co-lead the execution of one or more Phase 2 clinical trials in CKD, overseeing activities from protocol development through key milestones such as first patient in (FPI), interim analysis, database lock, and clinical study report completion.Oversee and manage external partners, including CROs, vendors, and global clinical sites.Ensure study conduct aligns with protocols, SOPs, and regulatory requirements, including ICH-GCP, through oversight of site monitoring and trial activities.Support the development and review of key study documents, including CRFs, informed consent forms (ICFs), and patient-facing materials.Represent Clinical Operations on cross-functional teams, including participation in Study Execution Team (SET) meetings.Collaborate with Clinical Operations and Clinical Science to support engagement with key opinion leaders (KOLs) and investigators.Qualifications & ExperienceBachelor's degree or higher in a scientific or healthcare-related field.At least 4 years of clinical research experience, including a minimum of 2 years in a Clinical Trial Manager role within a biotech, pharma company, or CRO environment.Experience supporting early to mid-stage clinical trials (Phase I–II preferred).Demonstrated ability to manage clinical trials from study start-up through close-out.Working knowledge of FDA regulations and ICH-GCP guidelines.Core CompetenciesStrong organizational and project management skills, with the ability to manage multiple priorities simultaneously.Clear and effective verbal and written communication skills.Proven problem-solving and negotiation capabilities.Ability to build and maintain strong relationships across internal teams and external partners.Willingness to take a hands-on approach and contribute across a wide range of clinical operations activities.Flexibility to travel as required based on study needs.Technical SkillsProficiency in Microsoft Office tools (Excel, Word, PowerPoint, Outlook, Project).Experience working with clinical trial systems such as Medidata Rave, Veeva, or similar platforms.