Clinical Team Lead
On-siteTokyo, Tokyo, Japan
Job Summary
Drive clinical delivery of research trials by overseeing site management, monitoring visit strategies, and vendor operations while ensuring adherence to regulatory requirements and SOPs. Lead the development of data-driven clinical project strategies, manage budgets and scope changes, and forecast revenue to meet contractual deliverables. Proactively identify risks across clinical, financial, and quality domains, facilitating communication with clients and matrixed stakeholders to maintain operational excellence. Mentor team members, present to leadership for new business opportunities, and oversee regulatory/ethics committee submissions. Requires 2+ years in clinical research, fluency in English, and ICH/GCP knowledge. Full-time role with up to 30% travel.
Required Qualifications
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
- Fluent in English, both written and verbal
- 2+ years clinical research/monitoring experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
- Experience managing projects in a matrix and virtual environment
- Excellent communication, planning and organizational skills
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
- Financial awareness and ability to actively and effectively utilize financial tracking systems
- Ability to work independently and mentor junior project team members
- Ability to negotiate and liaise with clients in a professional manner
- Ability to present to staff at all levels
- Weekend and off-hour work as required
- Travel Requirements: up to 30% (Global – primary domestic and international)
Desired Qualifications
- Master or other advanced degree
- PMP certification
- 2+ years CRA experience, on-site or in-house
- In lieu of the above minimum requirement, candidates with three or more years of relevance clinical research experience in pharmaceutical, CRO or health care setting
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