Study start up Specialist

1718 Roche Products Private Lt; Mumbai; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Roche in Mumbai is seeking a Study Start Up Specialist (SSUS) to drive efficient start-up processes for clinical trials. You will ensure regulatory compliance, coordinate with local country teams, CROs, and clinical sites to activate study sites promptly.

The role requires a life sciences degree with strong understanding of trial regulations, budgeting experience, and excellent organization. Fluency in English and local language(s) is expected, with a collaborative, cross-functional mindset.

Qualifications

• Experience with study start-up and regulatory compliance.
• Experience coordinating with global study teams, CROs, and vendors.
• Attention to detail in handling trial documentation and budgeting.

Responsibilities

• Support and execute study start-up strategies to accelerate site activations.
• Prepare regulatory submission packages for Health Authorities and Ethics Committees, including ICF adaptations.
• Collect, verify, and submit essential site documentation to TMF while ensuring compliance.
• Oversee site payments and contract negotiations, coordinating with finance and vendors.
• Identify potential start-up bottlenecks early and support local vendors and cross-functional teams.

Skills

Regulatory knowledge

Cross-functional collaboration

Documentation management

Budgeting & contracts

Organizational skills

English & local language

Education

Life sciences degree (MD/PhD/MA/MS/BA/BS)

Postgraduate/master’s degree desirable

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position 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.

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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.