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The PositionAffiliate: Roche Pharma Korea
Organization: Pharma - Product Development - Global Clinical Operations (PDG)
Reports to: Country Start Up Team Leader
Work location: Seoul, South Korea
Study Start Up Lead (SSUL)Purpose, Objectives and Scope of Position
As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff.
Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role.
Key Responsibilities
This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance.
Key responsibilities include:
- Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
- Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.
- Ensuring alignment with global strategies and timelines.
- Managing amendments throughout the study lifecycle.
- Identifying and driving opportunities for process automation, standardization, and innovation.
- Collaborating with regional and global counterparts to harmonize systems and improve timelines.
- Participating in external industry collaborations to influence country start-up environments.
- Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).
You will lead in a cross functional environment in multiple of the following areas below
- Study Start-Up Strategy & Execution
- Informed Consent Form (ICF) Management
- Site Documentation & Compliance
- Budgeting & Contract Management
- Payment Oversight
Qualifications
● Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent.
● 2–5 years of proven experience in clinical trial start-up and cross-functional collaboration as a CRA or SSU role.
● Strong understanding of ICH-GCP, and local regulatory environments
● Experience managing vendor/CRO relationships
Skills & Competencies
● Excellent communication and interpersonal skills
● Strong organizational, analytical, and problem-solving capabilities
● Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)
● Collaborative and adaptable mindset with attention to detail
● Ability to lead through complexity and ambiguity, especially in matrixed and global teams
● Fluency in written and spoken English is mandatory.
Submission
자유 양식의 국/영문 이력서 및 국/영문 자기소개서 (하나의 MS Word 혹은 PDF 파일로 제출)
※ 이력서 상단에 반드시 현재 연봉과 희망 연봉을 표기하시기 바랍니다. 누락 시 이력서가 검토되지 않습니다.
※ 이력서 내 이메일 주소와 서류전형 지원 사이트의 입력하시는 이메일 주소를 반드시 동일하게 작성해주시기 바랍니다.
※ 국가보훈대상 및 장애인은 관련 서류 제출시 관련 법규에 의거 우대합니다.
※ 이력서에 개인민감정보 (신체적 조건, 출신 지역, 혼인 여부, 가족관계 등)는 기재하지 말아주십시오.
※ 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후 라도 채용이 취소될 수 있습니다.
Process
서류 전형▶ 면접 전형 ▶ 종합 심사 ▶ 최종 합격
※ 면접은 서류전형 합격자에 한해 개별 통보합니다.
※ 면접 일정 안내 및 조율을 위해 해외 번호(중국)로 연락이 갈 수 있는 점 미리 안내드립니다.
※채용이 유력한 후보자에 대해서 이력 검증 및 평판 조회, 건강검진 등의 종합심사를 진행하여 최종 합격자를 선정합니다.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Skills Required
- Degree in life sciences or equivalent, including MD, PhD, MA/MS, or BA/BS
- 2-5 years of experience in clinical trial start-up and cross-functional collaboration as a CRA or SSU professional
- Strong understanding of ICH-GCP
- Knowledge of local regulatory environments
- Experience managing vendor or CRO relationships
- Excellent communication and interpersonal skills
- Strong organizational, analytical, and problem-solving capabilities
- Proficiency in clinical systems such as Veeva Vault, CTIS, and RIM
- Collaborative and adaptable mindset with attention to detail
- Ability to lead through complexity and ambiguity in matrixed and global teams
- Fluency in written and spoken English
Roche Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.
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Retirement Support — U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
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Leave & Time Off Breadth — Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
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Healthcare Strength — Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.
Roche Insights
What We Do
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
