Senior Lead Clinical Research Associate – NIS

Overview

In this role you drive global non-interventional studies as a Senior Lead CRA, guiding cross-country teams to ensure high-quality site management and compliance. You collaborate with Sponsors, PMs, and regulators to advance study start-up, monitoring, and close-out, shaping study delivery across regions. You’ll mentor CRAs, optimize processes, and uphold GCP and study protocols while contributing to Oracle’s mission in AI-enabled life sciences. This is a leadership position with a meaningful impact on patient outcomes and clinical research excellence.

Pay / Benefits

• flexible medical benefits
• life insurance
• retirement options
• volunteer programs
• inclusive/accessible workplace
• disability accommodations on request

Responsibilities

• Drive study start-up: assess feasibility, identify sites, and select sites with PMs and Sponsors
• Oversee contracts and budgets: review site contracts and budgets with CRA and contracting teams, involve contract specialists as needed
• Ensure regulatory compliance: coordinate with regulatory teams and CRAs to meet EC requirements and prepare site documents
• Lead study site management: supervise activation and ongoing monitoring per GCP, SOPs, and study plans
• Train and coordinate CRAs: mentor a cross-country team, create training materials, ensure quality site management
• Monitor progress and quality: maintain trackers, monitor CRA activities and site deliverables, escalate issues
• Foster team collaboration: act as main liaison between study team, Sponsor, sites, and CRAs, driving process improvements

Key requirements

• Bachelor in Life Sciences or related field; with minimum 3 years’ hands-on clinical research experience
• At least 3 years CRA experience including site initiation, TMF management, and site monitoring (clinical and non-interventional)
• Minimum 2 years Lead CRA experience coordinating CRA activities across multiple European countries
• Proficient English (C1); additional languages advantageous
• Technical proficiency with MS Office, EDC, CTMS; willingness to learn new systems
• Strong organizational, problem-solving, and cross-cultural skills
• Experience reviewing site contracts, budgets, and invoices
• Ability to work independently with attention to detail in a fast-paced environment

• Cross-cultural collaboration
• Teamwork and initiative
• Strong communication skills
• MS Office
• EDC
• CTMS

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