Connecting...
仕事詳細
| 勤務地: | 日本 |
| 給与: | ¥6000000 - ¥25000000 per annum |
| 職種: | 正社員 |
| 専門: | コンサルティング, 製薬・メディカルディバイス |
| 参照: | 57512 |
Function: Global Clinical Development / Clinical Operations
Therapeutic Area: Vaccines
Role Overview
A global pharmaceutical organization is seeking a Clinical Operations & Study Leader (COSL) to lead and coordinate clinical project and study operations within Vaccine development programs. This role combines end-to-end project oversight with hands-on study leadership, ensuring delivery of clinical milestones on time, within budget, and to quality standards.
The COSL acts as the operational leader within assigned projects, partnering closely with the clinical development strategy lead and serving as the central coordination point across global, regional, and local stakeholders.
Key Responsibilities
- Lead and manage clinical project and study operations across global development programs
- Provide operational input into clinical development strategy and governance
- Ensure delivery of clinical milestones (timelines, quality, budget)
- Coordinate cross-functional clinical teams and external partners (e.g. CROs)
- Drive feasibility, planning, and execution of clinical studies, including regulatory submissions and inspection readiness
- Act as the primary operational interface across multiple global functions
- Oversee risk management, issue escalation, and crisis management
- Ensure effective communication at project and study level
- Support innovation in trial design, digital methodologies, and operational tools
- Extensive experience in global clinical operations and study leadership
- Strong project management capability across complex, multi-country trials
- Proven leadership in cross-functional and multicultural environments
- Strong understanding of clinical development constraints, including Japan regulations
- Excellent communication and stakeholder management skills
- Master’s degree or higher in a scientific or medical field
- Minimum 8 years’ experience in pharmaceutical clinical research
- Full professional proficiency in English
- Strong local language capability
キャリア、ポジション等ご質問のある方はご連絡下さい。ぜひご連絡ください。