Global Clinical Trial Leader

Roche • South San Francisco, CA

41d • Onsite

About The Position

The Genentech Research and Early Development (gRED) Global Clinical Trial Leader (CTL) is accountable for the execution and delivery of early development global clinical trials under the leadership of the Sr. CTL. The CTL will actively contribute to the Protocol Execution Team (PET), is experienced at managing vendors, developing risk mitigation strategies and study plans. The CTL champions and supports change related to their study assignments and department goals/objectives. These complex programs focus on the rapid development of new molecular entities with limited or no clinical data, and as such, require implementation of novel and highly flexible global operational strategies. The Opportunity: Your responsibilities in this role will include:

Requirements

• Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred).
• 4+ years of study management experience desired
• Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
• Experienced at managing delegated aspects of one or more early development phases (I and II), global, complex, clinical studies and is generally experienced in clinical research/development.
• Recognized as experts in clinical trial management with thorough understanding of execution of clinical trials.
• Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week.

Responsibilities

• Provides operational expertise to one or more global cross-functional Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out)
• Creates a positive work environment by encouraging mutual respect, instills innovation and accountability on a functional and project level, both locally and globally to implement and deliver the study.
• Participates in developing, driving and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as vendor specifications, drug supply forecasting, monitoring and communication plans, quality of trial master files and quality of data in systems including CTMS.
• Collaborates with and influences cross-functional team members to solicit input on study plans and coordinates execution of effective investigator meetings.
• Participates in selection of vendors in collaboration with the PETL and oversees delegated outsourced activities to ensure CRO and vendors deliver against contracted scope of work.
• Provides input to the study budget and manages assigned vendor budget(s).
• Through strategic and critical thinking, contributes to managing timelines and critical study activities, identifies issues and proposes potential resolutions.
• Contributes to the identification, assessment and selection of countries and sites
• Contribute to the development of clinical trial protocols/informed consents and provide strategic operational input on protocol feasibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees