12 ago
|
Roche
|
Ciudad de México
12 ago
Roche
Ciudad de México
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, integral 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+
📌 Study Start-Up Specialist (Ciudad de México)
🏢 Roche
📍 Ciudad de México