Study Start Up Analyst

F. Hoffmann-La Roche AG; São Paulo; On-site; BRL 55,000 - 85,000; Full time

Job summary

Roche seeks a member of the PDG Country Study Start Up Team in São Paulo to drive efficient study start-up processes and support the delivery of clinical trials. You will collaborate with local and global teams and CROs to enable timely site activation and compliant documentation.

You will help prepare ICFs, support IRB/EC/HA submissions, manage submissions, collect site documents, and learn about ICH/GCP guidelines while developing practical start-up skills.

Qualifications

• Bachelor’s degree in life sciences or equivalent.
• Theoretical knowledge within the discipline and ability to organize simple tasks within existing procedures.
• Willingness to learn how the team’s work impacts the broader business.
• Fully fluent in written and spoken English.

Responsibilities

• Drive and facilitate efficient study start-up processes to contribute to delivery of clinical trials.
• Collaborate with local country teams, global study teams, and CROs to ensure seamless trial execution.
• Prepare and adapt Informed Consent Forms (ICFs) and assist with IRB/EC/HA submissions.
• Assist in preparing submission packages, respond to RFIs, and ensure timely TMF documentation.
• Collect and verify site documents (CVs, patient materials, biobank details) and support local vendors.
• Provide assistance with contract negotiations and updating contract system data for planning.
• Assist in overseeing site payments, escalations, and reporting to ensure financial compliance.

Skills

English fluency

Education

BA/BS in life sciences

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

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 country teams, global study teams, and CROs is essential to this role.

The Opportunity

• You are supporting and executing study start-up strategies for faster site activations, identifying issues, following regulations/SOPs, and assisting with Health Authority/Ethics Committee communication.
• You are assisting in preparing and adapting Informed Consent Forms (ICFs), supporting IRB/EC/HA submissions, and archiving approvals.
• You are preparing and managing submission packages, assisting in responding to RFIs, ensuring timely document submission to the TMF, and supporting study amendments.
• You are collecting and verifying site documents (CVs, patient materials, biobank details), learning local document needs, and supporting local vendors.
• You are providing assistance with contract negotiations and execution, collaborating with partners on compliance, and updating contract system data for planning.
• You are assisting in overseeing site payments, escalations, and reporting, ensuring financial compliance for local operations, and participating in accrual/purchase order planning.
• You are acquiring basic knowledge and practical skills in clinical trial start-up, learning about ICH/GCP guidelines, and assisting with process improvements based on your observations.

Who you are

• You hold a degree (BA/BS or equivalent) in life sciences or a related field.
• You have theoretical knowledge within the discipline gathered through higher-level education, and are capable of organizing simple tasks within existing procedures.
• You work effectively on assigned problem areas, follow instructions to resolve issues, and are eager to learn how your team's work impacts the broader business.
• You are fully fluent in written and spoken English.

Preferred

• A postgraduate degree or master’s degree in life sciences or equivalent is highly desirable.
• *Relocation benefits are not available for this posting.

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 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.