Sr. Study Manager, 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, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to lead clinical studies and experience multiple facets of Clinical Operations in a dynamic, supportive, collaborative, and global cross‑functional environment.

Under minimal supervision, leads and manages complex global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical studies are delivered within timelines, budget, and quality. A critical component of the position is leading, collaborating with and driving internal cross‑functional study teams and managing, contract research organization (CRO) personnel and other study vendors.

Performs assigned responsibilities to ensure timely completion of departmental goals and objectives.

• Assume overall responsibility for the planning and execution of one or multiple global trials by managing all aspects of trial deliverables, including development of timelines, budget, recruitment and country/site selection strategies, and provision of clinical trial materials.
• Serve as main study contact for the cross functional team, CROs, vendors and study sites.
• Monitor KPI and performance metrics and drive related discussions and escalations with the cross functional study teams and CROs/vendors. Escalate risks/issues and reports status to clinical operation lead.
• Participate in the preparation of protocols and Case Report Forms (eCRFs), monitoring, communication, and other project plans.
• Author and lead the coordination of study specific documents such as Informed Consent.
• Work with CROs to develop processes and mitigation strategies for assigned studies.
• Collaborate with Clinical Development and CRO on study‑specific training for study team and study sites.
• Responsible for the financial management of the clinical trial in conjunction with his/her supervisor and finance department, including contracts, change orders and invoices.
• Efficiently establish and monitor trial milestones as well as overall day‑to‑day operations of clinical studies, ensuring study information and timelines are accurate in internal electronic systems, reports and on government websites (CT.gov, etc.).
• Ensure the timely recruitment of trial participants with secure randomization processes, if applicable, and subsequent efficient and effective data management.
• Ensure compliance with and adherence to the project plan and identify, evaluate and mitigate potential risks and issues.
• Oversee systems to track projects including all study, investigator and ethical review board information, patient recruitment activity, and financial management.
• Liaise with the Trials Steering Committee, Data Monitoring, and Ethics Committee as required.
• Provide regular and ad hoc information, both written and verbal, to all the trial participants, internal/external teams including reports, updates, guidance, preformed commitments, etc.
• If required, conduct co‑monitoring visits with CROs or…