Clinical Trial Manager

The National Institute of Clinical Research is seeking a Clinical Trial Manager to join our dynamic, Huntington Beach, CA site. In this vital management role, you will oversee site-level operational processes and collaborate with senior leadership to plan and execute strategic initiatives. You will manage the logistical demands of multiple multidisciplinary clinical trials from the pre-study stage through post-closeout across various locations. Additionally, you will formally supervise, support, and mentor clinical staff—including Coordinators, Principal Investigators, and Sub-Investigators—to optimize patient flow and deliver exceptional performance. **Key Responsibilities** **1. Strategic Regional Operations & Site Management** - Manage and direct all clinical operations across the assigned regional hub or multi-site portfolio. - Collaborate with corporate leadership to develop and execute strategies aimed at expanding regional business operations. - Direct site management and ensure continuous regulatory and audit readiness across all managed trials. - Drive strategy execution for patient recruitment, enrollment, and retention goals. - Accountable for regional crisis management, issue escalation, and conflict resolution across sites. **2. Trial Planning & Execution** - Coordinate and conduct site initiation visits (SIVs), site training, and ensure site readiness for subject enrollment at activation. - Oversee day-to-day clinical trial activities to ensure protocol compliance, drug accountability, and seamless laboratory operations. - Oversee patient screening, enrollment, and consent processes. - Ensure timely and accurate data collection, query resolution, and safety/adverse event reporting into study databases. - Perform or provide direct oversight of Clinical Research Coordinator responsibilities, including subject visits, informed consent, source documentation, investigational product accountability, data entry, query resolution, scheduling, specimen processing, and sponsor communication when necessary to support site operations. - Serve as operational study support during staffing shortages, high enrollment periods, site start-up, or other situations requiring direct involvement in study conduct. **3. Leadership, Training, & People Management** - Lead hiring, onboarding, performance management, and offboarding for regional clinical staff. - Work closely with site managers and coordinators to oversee staff training, mentorship, and professional development programs. - Foster a culture of compliance, ensuring all clinical staff strictly follow GCP, SOPs, and institutional policies. - Lead by example by maintaining competency in all Clinical Research responsibilities and providing hands-on operational support when necessary. **4. Quality Assurance & Regulatory Compliance** - Conduct regular site audits to ensure absolute compliance with GCP, ICH guidelines, and regulatory requirements. - Prepare for, participate in, and manage sponsor monitoring visits, internal audits, and regulatory inspections. - Implement corrective and preventive actions (CAPA) as required. - Standardize, update, and implement institutional SOPs across assigned regional hubs. **5. Vendor, Administrative Management** - Manage cross-departmental collaboration with Regulatory, Data, and QA leadership. - Serve as the primary point of contact and manage relationships with external stakeholders, including sponsors, CROs, central labs, and regulatory authorities. - Maintain and oversee trial management systems (CTMS) and electronic trial master files (eTMF). - Prepare, synthesize, and distribute periodic operational metrics and site performance reports for executive leadership. **6. Essential Functions** - Perform and oversee all aspects of clinical trial operations from study start-up through closeout. - Maintain proficiency in Clinical Research Coordinator (CRC) responsibilities and perform CRC duties as needed to support study operations. - Conduct or a…