Clinical Data Management Head - Tokyo Wards, 日本 - Michael Page

As the Clinical Data Management Director for our client's Japan business, you will play a pivotal role in leading and managing a dynamic team of approximately 10 biometris professionals based in Tokyo. You will be responsible for overseeing all aspects of clinical data management operations in Japan, ensuring the highest standards of data quality, integrity, and compliance with regulatory requirements.

Key Responsibilities:

1. Team Leadership: Provide strategic direction, mentorship, and guidance to the clinical data management team in Tokyo, fostering a collaborative and high-performance work environment.
2. Project Management: Oversee the planning, execution, and delivery of clinical data management projects for multiple studies conducted in Japan, ensuring adherence to project timelines, budget constraints, and quality standards.
3. Client Engagement: Serve as a primary point of contact for clients in Japan, collaborating closely with project stakeholders to understand their needs, address concerns, and deliver tailored data management solutions.
4. Quality Assurance: Implement robust quality control measures to ensure the accuracy, completeness, and consistency of clinical trial data collected in Japan, conducting regular audits and reviews as needed.
5. Regulatory Compliance: Stay abreast of relevant regulations and guidelines governing clinical data management in Japan, ensuring adherence to local regulatory requirements and industry best practices.
6. Cross-functional Collaboration: Collaborate effectively with internal teams, including biostatistics, programming, clinical operations, and medical affairs, to support integrated project delivery and drive operational excellence.
7. Technology Utilization: Evaluate and leverage innovative data management technologies and tools to optimize processes, enhance efficiency, and streamline data collection, processing, and reporting activities.
8. Risk Management: Identify potential risks and challenges in data management processes, develop mitigation strategies, and proactively address issues to minimize impact on project timelines and deliverables.

   The Successful Applicant

9. Has practical experience in the clinical statistics department of a pharmaceutical company
   
   
10. Experience in creating statistical analysis plans or data management plans
    
    
11. Experience in discussions and negotiations with KOL (experts such as university professors) regarding clinical statistics
    
    
12. Has advanced problem-solving skills, negotiation skills, and management skills (more than 5 years of experience in organisational management)
    
    
13. Microsoft office basic application operation skills
    
    
14. Has general knowledge about clinical trials and fully understands its ethical principles.
    
    
15. Correctly understand the Pharmaceutical Machinery Law, GCP, and other regulations and rules regarding clinical trials.
    
    
16. Has expertise in clinical statistical analysis, data management, and relevant ICH guidelines What's on Offer
17. Opportunity to develop people management skills
    
    
18. Possibility to transition from CRO into a global pharmaceutical
    
    
19. Competitive compensation benefits