Clinical research

Job Description:

Experience: 4–10 Years
Location: Delhi / NCR
Language: Japanese – JLPT N2 or N1 preferred

✅ Must-Have Skills

🔬 Core Clinical Research Skills

• Solid knowledge of ICH-GCP guidelines

• Hands-on experience with clinical trial phases (I–IV)

• Experience in:

  • Site identification, initiation, monitoring, and close-out

  • Protocol adherence and regulatory submissions

  • SAE/AE reporting & handling deviations

  • Patient recruitment and site coordination

  • Documentation handling (eTMF, CRFs, ICFs, source documents)

• Familiarity with regulatory bodies like CDSCO (India) and PMDA (Japan) is a plus

💻 Technical Skills

• CTMS & eTMF tools: Medidata, Veeva Vault, Oracle Siebel

• EDC platforms: Medidata Rave, Inform, REDCap

• Proficient in MS Excel, Word, PowerPoint

• Clinical data review and reconciliation (if data-oriented role)

🌐 Japanese Language Proficiency

• JLPT N2/N1 certified

• Fluent in reading, writing, and speaking Japanese

• Able to translate clinical documents between Japanese and English

• Comfortable in verbal communication with Japanese clients/sites

• Understanding of Japanese healthcare & regulatory norms is a plus

⭐ Desirable / Value-Added Skills

• Experience working in global trials involving Japanese sponsors or sites

• Exposure to pharmacovigilance or regulatory writing is a plus

• Experience in training or mentoring junior team members

• Ability to liaise with Japanese clients or sponsors during audits, site visits, and virtual meetings