Clinical Trial Manager/ノンラインマネージャー/医薬開発本部クリニカルディベロップメントオペレーションズジャパンクリニカルトライアルマネジメント第１グループ (Shinagawa, Japan, Tokyo)
About this opportunity
Basic Purpose of the Job
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.
Key responsibilities:
Accurate planning and efficient trial execution
Provide leadership to Japan trial teams
Ensure delivery aligned with milestones and KPIs (e.g. MedEx)
Manage trial planning, implementation, tracking, and risk mitigation
Liaise with Clinical Trial Leader (CTL) and stakeholders
Communicate trial status and escalate issues
Senior CTM (G5):
Expert in clinical operations
Guide and mentor junior CTMs
Act as delegate of Country Trial Management Lead
Co-lead non-trial initiatives
May act as CTL for standalone Japan trials
Accountabilities
1. Trial Preparation
Ensure compliance with ICH-GCP, regulations, SOPs, and protocol
Manage and review Japan trial budget
Ensure training for internal and external partners
Plan timelines and coordinate feasibility
Validate site selection and patient commitment
Develop recruitment, engagement, and risk mitigation plans
Coordinate patient-facing materials
Oversee vendor outsourcing
Respond to Regulatory Authority/Ethics Committee inquiries
Performance Indicators:
Adherence to MedEx KPIs
Timely TMF documentation
Updated trial systems
Effective communication
Patient-centric initiatives implemented
2. Trial Conduct
Maintain GCP and regulatory compliance
Monitor risks and mitigation
Oversee budget and quality monitoring
Track patient recruitment progress
Support investigator meetings
Maintain relationships with sites, experts, and stakeholders
Participate in CD&O network
Performance Indicators:
Compliance maintained
Budget monitored
Trial oversight meetings documented
Core documents available on time
Timely responses to authorities
Vendor continuity ensured
Trial targets achieved
3. Trial Closeout and Reporting
Ensure timely data cleaning and delivery
Archive documents in TMF
Submit CTR to authorities
Share results with sites and patients
Performance Indicator:
Timeline adherence (e.g. database lock targets)
4. General Accountabilities
Maintain engagement with investigators and patient organizations
Ensure cross-functional collaboration
Support CTL and escalation processes
Contribute to Japan clinical development team (JCDT)
Provide early input into CDP/TDO
G5 Additional:
Lead initiatives within CD&O
Represent organization externally
Support CTM oversight and resolve complex issues
Leadership Competencies
Inspire and empower teams
Foster learning culture
Encourage innovation and smart risk-taking
Promote CD&O identity
G5:
Co-lead with Country Trial Management Lead
Embed empowerment culture
Regulatory / Organizational Requirements
Follow BI SOPs, business practices, and regulations
Maintain high ethical standards
Deliver quality work aligned with BI values
Job Complexity
Lead trial execution in Japan
Ensure patient safety and data integrity
Coordinate global, cross-functional teams
Manage regulatory and ethical complexity
Engage with external stakeholders
Interfaces
Works with:
CD&O and medical functions
HP functions (including patient advocacy)
CROs and suppliers
Investigators and site staff
Research networks
Patient organizations
Job Expertise
Strong clinical trial project management experience
Knowledge of project management and teamwork
Understanding of Japan regulations
Experience with CROs and patient organizations (preferred)
Strong communication and influencing skills
Job Impact
Accelerate delivery of therapies
Ensure compliance and quality
Safeguard patient safety and data integrity
Manage risks at Japan level
Minimum Education
University degree (e.g. Master’s) in relevant field
Biomedical Life Sciences preferred
Required Capabilities
Communication
Strong cross-functional communication
Cultural awareness and active listening
Scientific & Operational Expertise
Knowledge of trial planning and execution
Understanding of protocol, sites, patients, vendors
Leadership & Influence
Ability to lead teams and set direction
Inspire and align teams
Strategic Mindset
Future-oriented, analytical, innovative
Integrates study and portfolio strategy
Coordination & Oversight
Strong prioritization and resource management
Project Management
Planning, execution, transparency
Risk anticipation and resolution
G5:
Manage complex, large-scale trials
Handle multiple trials simultaneously
]]>
Job details
How this role compares
Computed from every other active Clinical Research role in our database, not just this employer's listings.
We currently track 41 comparable Manager Clinical Research roles across 13 biopharma companies.
Salary context
10 of 41 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 41 comparable roles
+ 7 more countries
Seniority mix
41 of 41 peers have a known seniority level
Therapeutic area mix
7 of 41 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.