※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
■Position Summary / Objective
- Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
- May serve as Clinical Trial Lead for one or more trials
- May lead or support trial level activities for one or more trials with the necessary supervision
- May co-lead study team meetings in partnership with RCO Protocol Manager and collaborate with cross-functional study team members
- May support clinical development planning and clinical development activities with the necessary supervision (e.g. collaboration with Japan Clinical Development Lead/Japan Clinical Trial Physician for provision and analysis of data to support future planning)
- Collaborate and liaise with external partners (e.g., KOLs)
- Seek out and enact best practices with instruction
- Provide regular and timely updates to manager/management as requested
- Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
- Conduct literature review
- Submit clinical documents to TMF
- Develop site and CRA training materials and present these at SIVs and Investigator meetings
- Review clinical narratives
- Monitor clinical data for specific trends; provide trends and escalate questions to Japan Clinical Trial Physician
- Develop Data Review Plan in collaboration with Data Management
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, HA, EC, IRB responses and contribute to regulatory submission.)
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their requirements
- Basic knowledge skills to support program-specific data review and trend identification
- Intermediate medical writing skills and medical terminology
- Basic planning/project management skills (develop short range plans that are realistic and effective)
■Key Competency Requirements
- Detail-oriented with commitment to quality
- Basic knowledge of disease area, compound, current clinical landscape
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Intermediate critical thinking and problem-solving skills
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
- A certain level of spoken and written English for business is required
※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.