Summer Intern - Clinical Trial Execution and Operations

2027 Summer Intern - Clinical Trial Execution and Operations

Princeton, NJ

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.

Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.

Our culture is grounded in our values:

Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.

We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at  .

Join the Clinical Operations team for a paid, hybrid summer internship offering hands-on exposure to how clinical studies are planned, activated, monitored, and maintained. Working alongside subject matter experts in Trial Execution, the intern will contribute to active operational priorities while learning how clinical development teams collaborate to deliver high-quality studies. The role includes preferred in-office time and direct guidance from experienced Clinical Operations experts.

What You Will Learn
:
By the end of the internship, you will understand how a clinical study progresses from planning and site activation through trial conduct and inspection readiness. You will build practical skills in essential document management, quality review, site support, issue tracking, process improvement, meeting documentation, and professional communication. You will also gain experience working across functions and learn how Clinical Operations partners with study teams and other stakeholders to execute trials efficiently and in compliance with Good Clinical Practice.

Key Responsibilities:

• Contribute to clinical trial execution activities with coaching and guidance from Clinical Operations team members, including:
  • eTMF and Document Management
    • Perform quality control checks on electronic Trial Master Files
    • Assist in compiling and reviewing essential document packets required to activate new clinical sites
    • Classify and tag uncategorized documents for audit preparedness
    • Provide support and become a key point of contact for contract and budget tracking related activities
  • Site Management and Monitoring Support
    • Assist the clinical trial execution team in monitoring trip report review
    • Assess site and master level Informed Consent documents to ensure compliance with company SOPs
    • Provide team assistance related to assigned Corrective Action Plans activities
  • Process Improvement and Departmental Initiatives
    • Optimize, maintain, and innovate trackers and tools utilized by the clinical operations team
    • Collate documents related to SOPs and training
    • Support ongoing initiatives to gather historical information on study specifics to develop a comprehensive and accurate database
  • Develop a practical understanding of Good Clinical Practice, company procedures, and clinical operations standards, and learn how these requirements…