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A clinical-stage biotechnology organization is seeking an experienced Senior CRA to support the operational execution of global Phase I/II clinical trials. This role focuses on study-level site and CRO oversight within a sponsor environment rather than routine field monitoring.
Job Responsibility:
Support the Global Clinical Study Lead/Senior Clinical Trial Manager in the operational management of Phase I/II trials from study start-up through close
Provide oversight of CRO monitoring activities, ensuring quality and adherence to protocol and GCP
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 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 I/II 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