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A growing biotechnology organization is seeking an experienced Senior CRA to support the operational execution of global Phase II/III clinical trials. This role emphasizes study-level site and CRO oversight within a sponsor environment rather than routine field monitoring. This role partners closely with Global Clinical Study Leads and Senior Clinical Trial Managers, as well as cross-functional teams, to drive study progress and ensure effective oversight of CRO partners and investigative sites. Ideal for experienced CRAs who have transitioned into in-house sponsor roles with study management responsibilities and are comfortable contributing to broader trial leadership activities. Preference for candidates located in Western U.S. time zones who can periodically collaborate with the clinical team in person. Remote candidates within the U.S. with the ability to travel occasionally will also be considered.
Job Responsibility:
Support the Global Clinical Study Lead / Senior Clinical Trial Manager in the operational management of Phase II/III trials from study start-up through closeout
Provide oversight of CRO monitoring activities, ensuring quality, protocol compliance, and GCP adherence
Act as a key point of escalation for site-related operational issues
Contribute to protocol development, study design discussions, and operational feasibility
Manage operational aspects of investigative site relationships and study execution
Oversee external vendors (IRT, eCOA, cardiac safety, patient reimbursement, etc.) and support vendor performance management
Participate in vendor selection activities, including RFP review and bid defenses
Support development and maintenance of study timelines, operational plans, and budgets
Contribute to the development of key study documents and site-facing materials
Support CRF design, UAT, edit check review, and data quality oversight
Ensure effective cross-functional coordination and study documentation
Requirements:
Bachelor’s degree in life sciences or related discipline
4+ years of in-house CRA experience within a sponsor or biotech environment
Experience supporting global clinical trials
Phase II/III trial experience required
Demonstrated experience in site oversight and vendor management
Experience contributing to clinical study management activities
Nice to have:
Prior experience working closely with Global Study Leads
Experience supporting CRO oversight within sponsor-led trials