※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
- Supports study feasibility and country patient commitments in collaboration with Country/Cluster Trial Monitoring and Medical. Collects and manages input to the study protocol, and operational aspects of the study
- Leads site selection in collaboration with Country/Cluster Trial Monitoring and Medical
- Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
- Works with local Drug Supply Management, aligned with BPA, to forecast local IMP and comparator needs as appropriate. Ensures IMP is available to commence and complete assigned trial/assigned trial sites
- Oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues, escalating as necessary
- Ensures sites are prepared for "Ready to Initiate Site" (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel
- Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
- Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets. Is responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
- Oversees local clinical team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Company standards and local and international regulations
- Leads/chairs local study team meetings or supports Sr. CSM in the conduct of local study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies or study sites
- Maintains oversight of country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
- Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary
- Tracks that all study close-out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
- A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
- Business Level English (oral and written)
- Minimum 5 years' experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of leading in a matrix environment, without direct reports
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (PMDA), local Health Authorities regulations and Company standards
- Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
- Communicates effectively in a local/global matrixed environment
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.