Study Start-Up Specialist

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

Are you passionate about clinical research and looking to expand your career by driving study start-up excellence in a global healthcare leader?

At Roche Global Clinical Operations (PDG), every site activation task brings us one step closer to delivering ground-breaking treatments to patients. As a Study Start-Up Specialist , you will play a crucial operational role in setting up clinical sites and coordinating trial initiation. Join a supportive team where your curiosity, dedication, and growth are continuously fostered.

The Opportunity

Execute core study start-up operations to ensure timely clinical trial initiation across Mexico.

Collaborate closely with country leads, global clinical teams, and external research sites.

Master state-of-the-art clinical trial technologies and digital management platforms.

Build a clear career development path within a culture of trust and shared impact.

Responsibilities

Coordinate end-to-end study start-up tasks from pre-study setup through complete site initiation.

Assist in drafting, translating, and tracking Informed Consent Forms (ICFs) and patient-facing materials.

Prepare and maintain regulatory submission packages, ethics committee documentation, and eTMF files.

Support site contract administration, budget tracking, and local vendor coordination.

Ensure strict adherence to ICH-GCP guidelines, local regulations, and Roche quality standards.

Who you are

You hold a University Degree in Life Sciences or an equivalent field.

You bring 2+ years of relevant experience in clinical trial operations or start-up support (e.g., CTA, CTS, or in-house CRA).

You have a solid understanding of ICH-GCP guidelines and basic knowledge of local clinical trial setup.

You display strong organizational skills, attention to detail, and a collaborative mindset.

You are fully fluent in written and spoken English and Spanish.

Preferred

Hands-on experience with clinical management systems such as Veeva Vault or CTIS.

Relocation benefits are not available for this position .

 

 

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.