What are the responsibilities and job description for the Clinical Trial Specialist position at SQA Solution?
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