Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die 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 aStudy Start Up Specialist (SSUS) within Roche Pharma Global Clinical Operations (PDG) based in Mumbai, you will play a crucial role in driving and facilitating productive 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.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

📌 Study start up Specialist (Mumbai)
🏢 Roche
📍 Mumbai