Tokyo, Kantō, Japan
Clinical Scientist
Job Description:
RESPONSIBILITIES:
- External facing clinical representative responsible for the independent clinical management of large, international clinical trials.
- Liaise with sponsors and sites; Oversee site rater qualification and training for Clinical Science.
- Review and monitor study level metrics; present study dashboards to sponsors as necessary.
- Ensure clinical quality standards are met.
- Ensure calibration of clinical team members and conduct rater training events as specified in Training plans.
- Assist with or take responsibility for the development of project deliverables
- Participate in the development, execution, and integration of research that tests the scientific and conceptual basis for the company’s approach to issues of applied measurement;
- Develop and maintain business and scientific relationships with external consultants, key opinion leaders, and Clinicians, both regionally and in research areas of interest, for the purposes of instudy delivery as well as academic projects
- Maintain calibration on relevant clinical scales.
- Identify the need for and develop as needed work instructions, process guidelines and standard operating procedures and ensure processes and procedures meet SOP/GCP requirements.
QUALIFICATIONS:
- Around 4 years’ experience administering psychiatric symptom rating scales and/or neurocognition scales, experience with structured diagnostic interviews preferred.
- Around 3 years’ experience in a clinical trial or research setting or other clinical setting preferred.
- Fluent in English, bi-lingual or multi-lingual skills are preferred.
- Basic understanding of GCP.
- Experience conducting assessments in CNS clinical trials as well as interacting with investigative sites and study sponsors.
- Proven project management experience at an intermediate level.
- Solid understanding of basic and intermediate statistics.
- Demonstrate negotiation skills; Ability to lead through influencing and negotiating.
Required Skills:
Interviews BASIC Metrics Calibration Tests Deliverables Instructions Statistics Integration Negotiation Research Project Management Science Business English Training Management