Study Start-Up Lead

Position:
Study Start-Up Lead

Company:
Roche

Location:
Mexico, Mexico City

Employment type:
Full time

Short Summary:
As a Study Start-Up Lead at Roche Global Clinical Operations, you will drive strategic country-level site activation, transforming regulatory complexity into streamlined trial delivery in high-impact therapeutic areas such as Oncology, Neuroscience, and Cardiometabolic diseases.

Responsibilities:
- Architect and execute country study start-up strategies and proactive risk mitigation plans.
- Oversee regulatory submission packages, Digipris/COFEPRIS workflows, and Single Ethics Committee processes.
- Strategically manage site documentation, ICF management, and clinical trial contract/budget negotiations.
- Act as the primary strategic point of contact for global study teams, local investigators, and CROs.
- Provide functional leadership, mentoring, and developmental guidance to Study Start-Up Specialists.

Requirement:
- University Degree (BA/BS, MS, PhD) in Life Sciences or a related field.
- 4+ years of solid experience in clinical trial operations, study start-up, or regulatory submissions in Mexico.
- Deep expertise in Mexican regulatory frameworks (COFEPRIS, Ethics Committees, Digipris) and ICH-GCP guidelines.
- Proven independence, strong problem-solving skills, and the ability to prioritize under pressure.
- Fully fluent in written and spoken English and Spanish.
- Preferred experience managing CRO relationships and therapeutic expertise in Oncology, Neuroscience, or Cardiometabolic trials.

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