Clinical Trial Specialist

Global Clinical Trial Leader

Type: Contract 1+ year, W2 ONLY

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 Te

amGenentech 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 availabl

e.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 initiative

s.
Key Responsibilit

iesClinical Trial Execution & Team Leaders

• hipProvide operational leadership and guidance to global cross-functional Protocol Execution Teams (PETs) throughout study start-up, conduct, and close-o
• ut.Foster a collaborative, innovative, and accountable team cultu
• re.Drive delivery of key trial documentation including vendor specifications, drug supply forecasts, monitoring plans, Trial Master Files (TMF), and CTMS da
• ta.Partner with stakeholders across functions to ensure successful study planning and executi
• on.Coordinate and support investigator meetin

gs.Vendor & Budget Managem

• entParticipate in vendor selection processes alongside Protocol Execution Team Leaders (PETL
• s).Oversee CROs and external vendors to ensure performance aligns with contracted deliverabl
• es.Provide input into overall study budgets and manage assigned vendor budge

ts.Clinical Strategy & Operational Excelle

• nceSupport country and site selection activiti
• es.Contribute operational expertise to protocol development and feasibility assessmen
• ts.Identify operational risks, manage timelines, and proactively implement mitigation strategi
• es.Maintain a patient-centric and site-centric approach across all trial activiti

es.Organizational Contribut

• ionPartner with colleagues across gRED and Roche to drive process improvements and establish best practic
• es.Serve as a Subject Matter Expert (SME) on targeted initiativ
• es.Mentor and coach junior team members and pee

rs.
Qualificat

ionsRequired Experi

• enceBachelor's degree or equivalent required; scientific or healthcare-related discipline prefer
• red.8+ years of clinical study management experie
• nce.Proven experience managing delegated aspects of global Phase I and Phase II clinical tri
• als.Demonstrated success managing CROs and external vend
• ors.Strong understanding of operational risk management and mitigation strateg
• ies.Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end-to-end drug development proc

ess.Leadership Competen

• ciesExcellent communication, influencing, and stakeholder management ski
• lls.Strong problem-solving abilities and comfort navigating ambigu
• ity.Growth mindset, intellectual curiosity, and commitment to continuous learn
• ing.Ability to operate independently while exercising sound judgment on when to seek guida
• nce.Passion for patient-focused clinical development and organizational change leaders

hip.Additional Informa

• tionSome travel may be requi