Clinical Trial Specialist

Overview Work Model : Hybrid (3 days onsite, 2 days remote; Tuesdays and Thursdays are anchor days) Schedule : Monday–Friday, standard business hours (8:00 AM–4:00 PM or 9:00 AM–5:00 PM PT) About the Team Genentech Research and Early Development (gRED) is seeking a Global Clinical Trial Leader (CTL) to support the execution and delivery of complex global Phase I and II clinical trials. Reporting under the leadership of a Senior CTL, this role focuses on the rapid development of innovative therapies and new molecular entities, often with limited clinical data available. The CTL plays a critical role in driving operational excellence across global studies, collaborating with cross-functional teams, managing vendors, mitigating risks, and contributing to strategic clinical development initiatives. Key Responsibilities Provide operational leadership and guidance to global cross-functional Protocol Execution Teams (PETs) throughout study start-up, conduct, and close-out. Foster a collaborative, innovative, and accountable team culture. Drive delivery of key trial documentation including vendor specifications, drug supply forecasts, monitoring plans, Trial Master Files (TMF), and CTMS data. Partner with stakeholders across functions to ensure successful study planning and execution. Coordinate and support investigator meetings. Oversee CROs and external vendors to ensure performance aligns with contracted deliverables. Provide input into overall study budgets and manage assigned vendor budget. Clinical Strategy & Operational Excellence Support country and site selection activities. Contribute operational expertise to protocol development and feasibility assessment. Identify operational risks, manage timelines, and proactively implement mitigation strategies. Maintain a patient-centric and site-centric approach across all trial activities. Organizational Contributions Partner with colleagues across gRED and Roche to drive process improvements and establish best practices. Serve as a Subject Matter Expert (SME) on targeted initiatives. Mentor and coach junior team members and peers. Qualifications Experience: Bachelor’s degree or equivalent required; scientific or healthcare-related discipline preferred. 8+ years of clinical study management experience. Proven experience managing delegated aspects of global Phase I and Phase II clinical trials. Demonstrated success managing CROs and external vendors. Strong understanding of operational risk management and mitigation strategies. Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end-to-end drug development process. Leadership Competencies Excellent communication, influencing, and stakeholder management skills. Strong problem-solving abilities and comfort navigating ambiguity. Growth mindset, intellectual curiosity, and commitment to continuous learning. Ability to operate independently while exercising sound judgment on when to seek guidance. Passion for patient-focused clinical development and organizational change leadership. #J-18808-Ljbffr SQA Solution