Study Start up Lead

1 semana atrás

São Paulo, Brasil Roche Tempo inteiro

Join to apply for the Study Start up Lead (SSUL) role at Roche .

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 Opportunity

  • Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders
  • Contribute as a member of the Country Leadership Team (LT) where applicable
  • Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance
  • Ensuring alignment with global strategies and timelines
  • Managing amendments throughout the study lifecycle
  • Identifying and driving opportunities for process automation, standardization, and innovation
  • Collaborating with regional and global counterparts to harmonize systems and improve timelines
  • Participating in external industry collaborations to influence country start-up environments
  • Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities)

Who you are

  • Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable
  • Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
  • Strong understanding of ICH-GCP, EU CTR, and local regulatory environments
  • Experience managing vendor/CRO relationships
  • Proven leadership or line management experience (for People Leads)
  • Fluency in written and spoken English is mandatory
  • Fluency in written and spoken language of the host country is mandatory

Relocation benefits are not available for this position.

Roche is an Equal Opportunity Employer.

Seniority level

Associate

Employment type

Full-time

Job function

Research, Science, and Engineering

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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