在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。 职位 A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. As a Study Start Up Specialist (SSUS) within Roche Pharma Global Clinical Operations (PDG) based in Mumbai, you will play a crucial role in driving and facilitating efficient study start-up processes to bring innovative clinical trials to patients. You will ensure seamless trial execution across various therapeutic areas by executing effective start-up strategies, maintaining strict regulatory compliance, and building trusted collaborations with local country teams, global study teams, and CROs. The Opportunity • Support and execute study start-up strategies to accelerate site activations, collaborating closely with internal teams, external partners, CROs, and clinical sites. • Prepare and manage regulatory submission packages for Health Authorities (HA) and Ethics Committees (EC/IRB), including adapting Informed Consent Forms (ICFs), responding to RFIs, and managing study amendments. • Collect, verify, and seamlessly submit essential site documentation (e.g., CVs, patient materials, biobank details) to the Trial Master File (TMF) while ensuring adherence to local regulatory requirements and SOPs. • Assist with the negotiation and execution of clinical trial contracts—managing confidentiality, indemnity, and amendments—while working with cross-functional partners to ensure legal and financial compliance. • Oversee site payments, coordinate accrual and purchase order reconciliations via shared service centers, and proactively manage escalations and reporting. • Act as a subject matter expert to identify potential start-up bottlenecks early, support local vendors, and keep systems updated with accurate tracking and contract data. Who You Are • You hold a university degree (MD, PhD, MA/MS, BA/BS) in life sciences or an equivalent field; a postgraduate or master’s degree is highly desirable. • You have a strong understanding of clinical trial regulations, Health Authority/Ethics Committee guidelines, and SOPs necessary for effective study start-up and execution. • You are highly collaborative and thrive in cross-functional environments, comfortably engaging with global study teams, CROs, clinical site staff, and local vendors. • You have a keen eye for detail with experience in managing complex documentation, budgeting, site payments, or contract negotiations. • You are highly organized and proactive, capable of managing multiple priorities, tracking systems, and compliance requirements efficiently. • You are fluent in both written and spoken English, as well as the local language(s) of the host country, enabling confident and clear communication with diverse stakeholders. 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。