Study Associate II, Clinical Operations

Posted Wednesday, January 14, 2026 at 5:00 AM

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy. We invite you to join us.

Hybrid

Employee Value Proposition:

At Taiho Oncology, our unwavering dedication to patients drives us to work collaboratively across various functions to achieve impactful results. The leadership and support provided by our Clinical Operations team are the cornerstone of our success in drug development. The role and contributions of our Study Associates are instrumental to our study teams’ success. The Study Associates' efforts directly contribute to the success of our trials and, ultimately, to the betterment of patient outcomes.

This position offers an exciting opportunity to be a part of a dynamic team cultivating growth and learning.

Position Summary:

The Study Associate II is accountable for the performance and compliance of an assigned protocol and sites. The incumbent supports Clinical Operations with the internal operational management of clinical studies, providing support for the planning, coordination, monitoring, tracking and general performance of clinical studies. A critical component of the position is providing support to the study team and/or lead specific operational activities, assisting with study start up activities such as feasibility, site selection, co-monitoring, site communications and other related study documentation and management activities.

In collaboration with the study manager, providing oversight of the contract research organization and other vendors performance to ensure quality and study timelines are maintained. The Study Associate II may lead a study of limited scope and complexity.

Performance Objectives:

• Guides study site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability in partnership with CRO.
• Reviews Monitoring Visit Reports (SEV, SIV, IMV, COV) from the CRO to ensure that sites are in compliance with the study and protocol. Reviews monitoring and other study operation plans and track related trends.
• Tracks monitoring related issues, risks, or findings with Investigators/site staff, and escalates to the Study Manager and/or CRO as needed.
• Attends co-monitoring visits as required per the CRO Oversight Plan, or as needed by Sponsor.
• Participates and provides input to study start-up activities including feasibility, site budget/contract review, Investigator Meetings, enrollment planning, and Investigator selection.
• Leads or supports study TMF by reviewing the TMF plan, oversees TMF set-up, study team training, periodic quality review, and document management. Reviews and maintains TMF documents, including documents related to IP release. Collaborates with team members on TMF related key performance indicators.
• Collaborates closely with study management, CRO study managers, and CRO monitoring staff, in reviewing site/patient activity tracking and preparing study updates. May support the oversight of the CRO/vendor to ensure outsourced activities are executed according to the contract and with high quality. Provides updates to the study team on the progress of CRO/vendor’s…