Country Study Start up Team Leader (cSTL)

Roche; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading global healthcare company in São Paulo seeks a Clinical Trial Start-Up Lead to oversee the initiation of clinical trials. This pivotal role requires experience in regulatory submissions, cross-functional collaboration, and strong leadership skills. Candidates should possess a degree in life sciences and fluency in English and the local language. Relocation benefits are not available for this position.

Qualificações

• Demonstrated experience in clinical trial start-up.
• Strong understanding of ICH-GCP and local regulatory environments.
• Fluency in written and spoken English is mandatory.

Responsabilidades

• Drive and facilitate efficient study start-up processes.
• Oversee start-up operations ensuring regulatory compliance.
• Engage with government and institutional bodies regarding clinical trial policies.

Conhecimentos

Regulatory submissions

Cross-functional collaboration

Leadership

Clinical trial management

Communication skills

Formação académica

Degree in life sciences or equivalent

Postgraduate degree or master’s degree

Descrição da oferta de emprego

Overview

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.

A healthier future. That’s what motivates us to innovate. Continuously promote science and ensure that everyone has the health care they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

Responsibilities

As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role.

This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance.

The Opportunity:

• Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.
• Managing amendments throughout the study lifecycle, ensuring alignment with global strategies and timelines.
• Identifying and driving opportunities for process automation, standardization, and innovation.
• Collaborating with regional and global counterparts to harmonize systems and improve timelines, as well as 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).
• You will lead in a cross functional environment in multiple of the following areas: Study Start-Up Strategy & Execution; Informed Consent Form (ICF) Management; Clinical Trial Submissions & Regulatory Coordination; Site Documentation & Compliance; Budgeting & Contract Management; Payment Oversight.

Qualifications

• 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. #ClinOps

About Roche

Roche is an Equal Opportunity Employer.

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.