Study Start Up Analyst
Roche
Sao PauloPosted Discovered via the company's careers siteMatch locked
Full time
About the role
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.
Not included in the source posting: benefits.
Skills
gcp
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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