Independent Clinical Monitoring Lead
800万円 - 1200万円
Act as Representative for Japan for Global Trials
Contribute to Safe Execution of Clinical Trials
- US Pharmaceutical company with rich development pipeline in oncoloy, immunology, neuroscience
- Strong career development opportunities
- Leading pharmaceutical company globally
- Responsible for overseeing country level operational activities of outsourced unblinded Site Managers including to site pharmacy staff training, Investigational Product (IP) management for blinded studies, IP/dosing related issues, unblinded Protocol Deviation (PD) and issue escalation and resolutions, and monitoring pharmacy compliance with the protocol and study procedures in a blinded manner, company's Standard Operating Procedures (SOP), code of Good Clinical Practice (GCP), applicable regulations and guidelines.
- 8 years' clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
- Experience with clinical trial related activities at the site pharmacy (e.g. temperature monitoring, drug accountability, pharmacy monitoring)
- Understanding of the drug development process, including ICH, GCP guidelines and local regulatory requirements
- Knowledge of system/ technology (e.g. IWRS, EDC, etc.) is required
- Excellence organization and time management skills, attention to detail, and ability to multi-task in environment with shifting priorities
- Proficient Microsoft applications (Excel, PowerPoint, etc.)
- Ability to fluent at speaking and writing both Japanese and English, with good written and oral communication skills.
- Demonstrate innovative spirit and strong interpersonal and leadership skills
- Good problem-solving skills.
- Excellent knowledge of different communication tools available
- A good understanding of global development process / environment
- Excellent communication skill and ability to establish strong relationship in matrix environment
- Flexibility to work in a rapidly changing environment with the sense of urgency
- Lead and manage clinical operations as a member of Japan R&D
- Diverse internal career development opportunities
- Contribute to rich development pipeline in leading global pharmaceutical company
- Opportunity to work on global projects