Note: Applicants must have permission to work in Japan and Fluent ~ Native level Japanese
- Oversee the activities of Independent Drug Monitoring process for all JCO managed studies. For Japan single country study provide input to and development of pharmacy related materials (e.g., forms and manuals) and system set-up and maintenance (e.g., IVRS and EDC)
- Lead study teams in management of the independent Drug Monitoring process as study IDMM if required for Japan single country study.
- Act as the primary point of contact for Global IDM Manager function in Global Trial Coordination
- For Japan single country study, work closely with Japan Clinical Operation Leader (JCOL), Data Manager (DM) Trial Supply Manager (TSM) and other functions during planning, study start up, execution and study closure to oversee entire IDM activities as needed.
- Lead and coordinates local IDM Leader and IDM team activities in compliance with SOPs, other procedural documents and applicable regulation to ensure inspection readiness.
- Lead and coordinate IDM related issue resolution with relevant stakeholder in global and Japan as well as CRO partner.
- Oversee the IDM monitoring activities and ensure investigational product issues are addressed at site.
- Monitor the pharmacy compliance by reviewing system reports, study-specific trackers, and other tools, as needed. Provide pharmacy compliance status, trends, and risk (when identified) to study team with action taken.
- Investigate urgent/ critical unblinded and pharmacy-related issues and coordinate resolutions. Escalate to study team in blinded fashion and ensue pharmacy related issued and Protocol Deviations (PDs) are resolved and documented.
- Sampling review IDM monitoring visit reports (initiation, routine, non-routine, off-site, and closure) and provide feedback, for the purpose of oversight as necessary to the CRO.
- Ensure the collection and filling of the study essential documents are completed as per established timeline and/or governing SOPs.
- Support the pharmacy/ IP related inspection readiness activities and provide inputs and follow up on audit CAPAs.
- Assist in Database Locks (DBL) and reviewing unblinded queries, as needed.
- Generate metrics, as required.
- Minimum of 8 years of 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
- BS degree or equivalent, related experience required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)