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About the Role
Support the execution and delivery of complex early-phase global clinical trials (Phase I/II) for innovative new molecular entities. Provide operational leadership across study start-up, conduct, and close-out while coordinating cross-functional teams, CROs, and vendors.
Responsibilities
- Provide operational leadership to global Protocol Execution Teams (PETs) throughout the trial lifecycle.
- Support study planning, site/country feasibility, protocol execution, timelines, and risk mitigation.
- Manage CROs/vendors, including performance, scope, deliverables, and assigned budgets.
- Drive key study documentation, including TMF, CTMS, monitoring plans, drug supply forecasting, and vendor specifications.
- Collaborate with cross-functional teams and investigators to ensure successful trial execution.
- Identify operational risks, bottlenecks, and issues and develop practical solutions.
- Contribute to process improvements and operational best practices across gRED/Roche.
- Support a patient- and site-centric approach to clinical trial execution.
- Act as an SME, mentor colleagues, and contribute to organizational change initiatives.
Requirements
- Bachelor’s degree or equivalent; scientific/healthcare discipline preferred.
- 8+ years of clinical study management experience preferred.
- Hands-on experience managing delegated aspects of global Phase I/II clinical trials.
- Strong CRO/vendor management experience.
- Knowledge of GCP/ICH, international regulatory requirements, and end-to-end drug development.
Location
- SSF, CA
Work Type
- Hybrid
- Long Term Contract
Experience Level
- 8+ years
Education Level
- Bachelor's degree
Salary/Compensations
- $103/hr
Benefits
- Medical
- Paid Sick leave
- 401K
About the Company
- Our client, a world leader in life sciences and biotechnology.