한성대학교

부서

모집분야

담당업무 및 지원자격

구분

지역

 Disease Management Solutions

Clinical Research

Associate

Affiliate: Roche Diagnostics Korea

Division : Disease Management Solutions

Work location: Seoul, South Korea

Your key responsibilities

• Roche Sponsored Studies(RSS) Protocol Development Support and Budgeting
• Coordinating Investigator Initiated Study(IIS) for internal review and tracking IIS status
• Ensuring the product meets all government regulations and standards
• Assists in all aspects of study design, implementation, and administration, ensuring compliance with IRB.MFDS requirements, regulations, and grant and/or contract
• Perform activities in the preparation, initiation, monitoring and closure for an agreed number of sites in all Roche Sponsored Studies(RSS) according to RDK Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations
• SOP Development and Revision
• To ensure quality and quantity commitments are achieved in a timely manner.
• Communication with internal employee to find unmet needs of internal customers and involve in evidence generation strategy for product launch, premium price and product claims.
• Training, supervising and supporting to CRA

Who you are

Education & Qualification 

• Bachelor degree above, in pharmacy, nurse, science or related discipline preferred
• Experience 
• +3~10 years of relevant working experience preferred in healthcare industry (The position title will be determined in accordance with the company's standards)
• Clinical research related experience preferred
• Proven Project/product management experience
• Provide clinical input and support for planning post-market launch
• Competencies 
• Makes strategic decisions in partnership with stakeholders
• Medical writing and speaking
• Understanding on scientific and medical publication
• Strong knowledge in KGCP, ICH-GCP
• Skills in documentation and archiving
• Ability to priorities, plan& evaluate deliverables
• Good command of spoken and written English
• Good oral and written communication skills
• Computer literacy desirable
• Teamwork and Collaboration

정규직

서울

자녀학자금 지원(유치원~대학생)

Mileage system: 카페테리아식 복리후생

장기근속자 해외여행 포상휴가 지원

임직원 단체보험 가입

Roche 자사 주식 구입 지원

Babysitting Fee 지원

Hobby Club

개인연금 지원

콘도 지원