Study Start Up Lead (SSUL)

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职位

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:

● Lead teams in the creation of the study start-up strategy and execution of the study start-up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners.

Informed Consent Form (ICF) Management:

● Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices

Clinical Trial Submissions & Regulatory Coordination:

● Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.

Site Documentation & Compliance:

● Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed.

● Oversee translation and approval of drug labels and patient-facing materials, as required ● Maintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs

Budgeting & Contract Management:

● Provide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value-based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity/insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting

Payment Oversight:

● Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.

Qualifications

● Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable

● Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration

● Strong understanding of ICH-GCP, EU CTR, and local regulatory environments

● Experience managing vendor/CRO relationships

● Proven leadership or line management experience (for PLs)

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.

● Fluency in written and spoken language(s) of the host country is mandatory.

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。