Study Start-Up Specialist

Position:
Study Start-Up Specialist

Company:
Roche

Location:
Mexico City, Mexico

Employment type:
Full time

Short Summary:
Are you passionate about clinical research and looking to expand your career by driving study start-up excellence in a global healthcare leader? As a Study Start-Up Specialist, you will play a crucial operational role in setting up clinical sites and coordinating trial initiation.

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.

Requirement:
- 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.

Benefits:
- Relocation benefits are not available for this position.