Clinical Trial Manager - Clinical Development Operations

4w1 month ago

Boehringer Ingelheim

Tokyo, JP · Full-time

About this role

The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, set-up, execution, and delivery of assigned clinical trials at the Japan level. This role ensures accurate planning and efficient trial execution while providing leadership to Japan trial teams.

Day-to-day responsibilities include managing trial planning, implementation, tracking, and risk mitigation, as well as liaising with the Clinical Trial Leader (CTL) and key stakeholders. The CTM communicates trial status, escalates issues, and ensures delivery aligned with milestones and KPIs such as MedEx.

This position operates within the Japan Clinical Development Operations group, collaborating closely with cross-functional teams, investigators, and patient organizations. The CTM contributes to the Japan clinical development team (JCDT) and provides early input into the Clinical Development Plan (CDP) and Trial Design Overview (TDO).

For experienced candidates, the Senior CTM (G5) role offers the opportunity to guide and mentor junior CTMs, act as delegate of the Country Trial Management Lead, and co-lead non-trial initiatives. Senior CTMs may also act as CTL for standalone Japan trials, representing the organization externally.

Requirements

Expertise in clinical operations and ICH-GCP compliance
Experience in trial preparation, conduct, and closeout within the pharmaceutical industry
Ability to manage trial budgets, timelines, and risk mitigation plans
Strong leadership skills to guide trial teams and mentor junior CTMs (for Senior CTM level)
Proven ability to coordinate feasibility, site selection, and patient recruitment
Experience responding to Regulatory Authority and Ethics Committee inquiries
Familiarity with TMF documentation and trial management systems
Fluency in Japanese and business-level English (inferred for Japan-based role)

Responsibilities

Provide operational and scientific oversight for assigned clinical trials at the Japan level
Manage trial planning, implementation, tracking, and risk mitigation
Liaise with Clinical Trial Leader (CTL) and stakeholders to ensure alignment
Communicate trial status and escalate issues as needed
Ensure compliance with ICH-GCP, regulations, SOPs, and protocol
Manage and review Japan trial budget, including vendor outsourcing
Oversee trial closeout, data cleaning, TMF archiving, and submission of CTR to authorities
Maintain engagement with investigators and patient organizations to support patient-centric initiatives

Benefits

Opportunity to lead and influence clinical trials at a global pharmaceutical company
Mentorship and career development through senior-level guidance and non-trial initiatives
Collaboration with cross-functional teams and external stakeholders
Patient-centric work environment with focus on innovative trial approaches