※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
The AD Project Management Country Operations (AD PMCO) is responsible for the successful execution of study deliverables and the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP),evolving regulatory requirements, and ensuring quality and consistency of monitoring activities.
The AD PMCO is accountable for coordinating rapid start up activities across assigned countries together with the CRO. The AD PMCO will also drive adherence to timelines and milestones of study goals as well as identifying and communicating risks to the study team.
The AD PMCO will ensure that the CRO assigned, FSP or in house CRA monitoring activities at study sites results in the effective identification and problem solving of issues.
Works with the CRO to revise study specific country plans and timelines. Accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations Ensures that the studies assigned in the country are appropriately resourced.
The AD PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training.
Attendance at site visits as required together with the CRO, FSP CRA or in house CRA as applicable or with Global Medical Affairs personnel for Sponsor Oversight, Inspection Readiness or Engagement Visits.
- Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies)
- Proactive reporting of study-specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO)
- Quality of monitoring oversight in the country for assigned study(ies)
- Meeting recruitment targets for assigned study(ies)
- CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party)
- Negotiation of site study budgets
- Oversight of FSP and /or contingent workers on assigned study(ies)
- Review if local regulatory documentation and oversight of local regulatory activities
- Relationship management with the national coordinating investigator as applicable
- Timely and accurate responses to queries from the study team
- Working with Medical Affairs to coordinate site feasibility and engagement activities
- Scheduling and leading effective country calls with local study team and/ or CRO
- Resolving ICF issues in country
- Oversight of EC submissions and facilitate resolution of queries
- Proposing potential investigator sites (HCO accountable for selection)
- Conduct trainingof CRAs
- Review Clinical Monitoring Documentation
- Inspection readiness activities
- Relationship management with sites
- Provide feedback to Internal and External Stakeholders as appropriate
- Develop and maintain tracking tools
- Drives quality efforts to proactively identify and manage risks to study quality
- Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process
- Solid knowledge of clinical development processes
- 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
- Comprehensive and current regulatory knowledge, including GCP
- Experience conducting GCP or other training is a plus
- Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 20% 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
1st: Hiring manager + HR
2nd: R&D VP + HR Senior Manager
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.