Japanese - English Bilingual Internal Recruiter specialized in Medical, IT, Finance, Procurement, HR, Commercial and External Affairs roles for pharmaceutical industry.
Japanese - English Bilingual Internal Recruiter specialized in Medical, IT, Finance, Procurement, HR, Commercial and External Affairs roles for pharmaceutical industry.
PRINCIPAL DUTIES AND RESPONSIBILITIES
Clinical Study Director (CSD): medical supervision and medical management of oncology phase I, phase II to IV clinical trials.
- Provide appropriate medical input for patient recruitment and retention strategy.
- Provide integrated medical/operational assessment of clinical study protocols: including impact on feasibility/enrolment of protocol features/requirements.
- Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts.
- Prepare and/or approve any documents related to the study and requiring a medical expertise.
- Prepare and/or organize and/or participate to meetings of investigators, Steering Committees, and Data Monitoring Committee.
Medical Advisor (MA): medical supervision and medical management of clinical trials.
- Provide appropriate medical feedback to clinical trial team.
- Prepare and provide key medical information to investigators and/experts in respect with communication policies (e.g. study results, DMC advice).
- Maintain and expand network with local potential investigators or experts/KOLs (Key opinion leaders).
- Liaise with local Medical Affairs to manage investigators and compounds.
Ensure medical accuracy of patient data especially for critical cases (e.g. outcome events, related SAEs and AEs with prespecified monitoring).
- In accordance with the local law and SOP, the SAEs responsible for reporting are transmitted to investigators and concerned IRB/Ethics Committee in a timely fashion.
- Support monitoring team and CSO, and achieve data quality.
Ensure medical & scientific training and medical information to study team(s), CSU and investigators.
- Acquisition of medical knowledge of study team(s) improves the quality of clinical study and will lead to the customer’s satisfaction