Johnson & Johnson Careers
[Janssen] SSU Lead
Requisition ID: 1905777045W
Johnson & Johnson is the world's most
comprehensive and broadly based healthcare Company, touching the lives of
nearly a billion people every day. Our Family of Companies throughout the world
compete in consumer, pharmaceutical, and medical devices and diagnostics
markets and have the skills and resources to tackle the world's most pressing
- 계열사: 한국얀센
- 포지션: SSU Lead (Sr. Local Trial Manager)
- 근무지: 서울시 용산구
- 근무형태: 정규직 (regular)
Performs the role of Local Trial Manager (LTM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. LTM is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries. The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants Site Managers and LTMs. The LTM may have some site management responsibilities.
1) A minimum of a BA/BS degree is required.
2) A degree in a health or science related field is preferred.
3) A minimum of 6 years of clinical trial monitoring experience is required.
4) Project manager experience is preferred / lead CRA experience is required at least.
5) Specific therapeutic area experience may be required depending on the position. (Oncology experience preferred)
6) Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
7) Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
8) Proficient in speaking and writing the country language and English. Good written and oral communication skills.
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- J&J Korea Linkedin: https://www.linkedin.com/in/country-recruiter-talent-acquisition-296167147/
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Janssen Korea, Ltd. (7220)
Clinical Trial Administration