※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
The Site Management Lead (SML) is accountable for overseeing outsourced (to CRO), FSP or in house CRAs (as applicable) including start up and monitoring activities to ensure the quality execution of protocol procedures, adherence to good clinical practices (GCP), evolving regulatory requirements and consistency of monitoring activities.
The SML is accountable for ensuring the CRO, FSP or in house CRAs monitoring study sites results in effective identification and problem solving of issues. Findings and solutions will be communicated to both our company and the CRO as applicable.
The SML supports the CRO staff, particularly CRAs as well as FSP or in house CRAs to understand complex protocol processes and procedures.
- Act as company's point of contact for the site: develop and maintain productive relationships
- Assessment of site monitoring activities undertaken by the CRO personnel, FSP and in house CRAs and any requisite escalation
- Identifying any site and/or CRA performance issues, quality events or any other quality issues at the patient and/or site level
- Proactively oversee start up processes to ensure expeditious start up of studies within geographical remit
- Addresss protocol-related training gaps for FSP CRAs
- Communicate clinical site assessment information to the Project Manager Country Operations (PMCO) and/or the CRA
- Conduct Sponsor Oversight Site Visits (SOSV) to assess site and CRA performance
- Maintain tools ot document and track clinical monitoring activities
- Supporting inspection readiness activities at the site level, with geographical remit
- Support implementation of CAPAs as necessary
- CRA resourcing across allocated studies
- Provide feedback to Internal and External Stakeholders as appropriate
- Extensive site management and monitoring experience across a range of highly complex disease areas
- Demonstrated capability of effective monitoring and site oversight
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Ability to lead, troubleshoot and influence for quality and delivery
- A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
- Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
- Experience in all study phases and in rare medical conditions preferred
- Previous oversight and regulatory inspection experience preferred
- Comprehensive and current regulatory knowledge, including GCPs
- Experience conducting GCP or other training is a plus
- Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 70% during busy periods)
- Good organizational skills and ability to deal with competing priorities
- Effective communication skills (written, verbal and presentation)
- Creative thinker, curious and unafraid to ask questions
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
- Proficient with MS Office Suite (Excel, Word and PowerPoint).
※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.