Clinical research-Japanese/ Chinese
- Mumbai, Maharashtra
- Permanent
- Full-time
Location: Delhi / NCR
Language: Japanese – JLPT N2 or N1 preferred✅ Must-Have Skills🔬 Core Clinical Research SkillsSolid knowledge of ICH-GCP guidelinesHands-on experience with clinical trial phases (I–IV)Experience in:Site identification, initiation, monitoring, and close-outProtocol adherence and regulatory submissionsSAE/AE reporting & handling deviationsPatient recruitment and site coordinationDocumentation handling (eTMF, CRFs, ICFs, source documents)Familiarity with regulatory bodies like CDSCO (India) and PMDA (Japan) is a plus💻 Technical SkillsCTMS & eTMF tools: Medidata, Veeva Vault, Oracle SiebelEDC platforms: Medidata Rave, Inform, REDCapProficient in MS Excel, Word, PowerPointClinical data review and reconciliation (if data-oriented role)🌐 Japanese Language ProficiencyJLPT N2/N1 certifiedFluent in reading, writing, and speaking JapaneseAble to translate clinical documents between Japanese and EnglishComfortable in verbal communication with Japanese clients/sitesUnderstanding of Japanese healthcare & regulatory norms is a plus⭐ Desirable / Value-Added SkillsExperience working in global trials involving Japanese sponsors or sitesExposure to pharmacovigilance or regulatory writing is a plusExperience in training or mentoring junior team membersAbility to liaise with Japanese clients or sponsors during audits, site visits, and virtual meetings