Study Associate , Clinical Operations

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.

At Taiho Oncology, our 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 and the purpose and contributions of our Study Associates are instrumental to our study teams. 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.

The Study Associate (SA) I is responsible for operational study support during study start‑up, maintenance, and close‑out. The SA I helps with the coordination of project activities, including corresponding with internal and external team members globally, assisting, updating of study trackers and systems and overseeing study documentation and Trial Master File. The SA supports the Clinical Operations department with developing processes and procedures and sharing lessons learned.

• Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies.
• Updates internal study trackers, dashboards, and systems with accurate study information (enrollment, study systems and tools/trackers, study team contact list, etc.).
• Responsible for the review of the TMF plans to ensure consistency across studies and alignment with internal TMF procedures.
• Monitors Trial Master File related KPIs and performs quality review of the eTMF (per CRO oversight plan) while collaborating with internal and CRO study teams to resolve any issues and risks.
• 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 tracks related trends and KPIs.
• Provides support across all study phases, including but not limited to vendor set‑up, enrollment, site‑related documentation, and inspection readiness.
• Collaborates closely with study manager to align expectations and study priorities for support.
• Manages access to internal study systems for applicable internal and external study team members.
• Assists with the onboarding of new hires, when applicable regarding system access or internal processes.
• May review and approved site level informed consents as compared to the master informed consent.
• Reviews and approves site budgets and escalates any issues to the study manager.
• Reviews and approves essential documents (green light) for drug release.
• Proactively incorporates learning and recommendations from other teams and practices and promotes standardization and efficiency in operations practices and processes ensuring consistent delivery across studies.

• Associate’s degree or equivalent. Bachelors’ degree in biological sciences is preferred.

• 2 years of relevant clinical trial support or site management experience in the pharmaceutical, biotechnology, CRO and/or healthcare…