Study Start Up Lead (SSUL)

Roche; Argentina; Presencial; ARS 9.750.000 - 12.500.000; Jornada completa

Descripción de la vacante

A global healthcare company seeks a Country Study Start-Up Team Leader responsible for initiating clinical trials. You will develop strategies, oversee start-up operations, and ensure regulatory compliance while leading teams. The ideal candidate will possess a degree in life sciences and experience in clinical trials. Fluency in English and Spanish is required. Join us to advance science and deliver impactful healthcare solutions.

Formación

• Proven experience in clinical trial start-up.
• Strong knowledge of ICH-GCP, EU CTR, and local regulatory frameworks.
• Ability to guide teams in complex, global environments.

Responsabilidades

• Develop and implement effective study start-up strategies.
• Oversee start-up operations, including site activation.
• Manage clinical trial submissions and documentation.

Conocimientos

Clinical trial start-up expertise

Regulatory submissions

Vendor/CRO management

Leadership skills

Problem-solving skills

Fluency in English

Fluency in Spanish

Educación

Degree in life sciences (MD, PhD, MSc)

Postgraduate degree preferred

Descripción del empleo

The Position

As a Country Study Start-Up Team Leader at Roche, you will be responsible for the efficient and compliant initiation of Roche-sponsored clinical trials. In this role, you will create and implement start-up strategies, oversee trial initiation, and ensure regulatory compliance while fostering innovation and operational excellence. You will collaborate with internal and external stakeholders across local, regional, and global levels, ensuring alignment with Roche’s global priorities and delivering value for patients, investigators, and partners.

The Opportunity

• Develop and implement effective study start-up strategies that ensure timely and compliant trial initiation.

• Oversee start-up operations, including site activation and regulatory coordination, ensuring adherence to global standards.

• Lead the preparation, submission, and archiving of Informed Consent Forms (ICFs).

• Manage clinical trial submissions, amendments, and site documentation throughout the study lifecycle.

• Drive process improvements, including automation, standardization, and innovation at country and site levels.

• Oversee budget planning, contract management, and payment processes, ensuring legal and financial compliance.

• Collaborate with CROs, authorities, and industry stakeholders to improve timelines and influence the clinical trial environment.

Who You Are

• Degree in life sciences (MD, PhD, MSc, or equivalent); postgraduate degree preferred.

• Proven experience in clinical trial start-up, regulatory submissions, and vendor/CRO management.

• Strong knowledge of ICH-GCP, EU CTR, and local regulatory frameworks.

• Excellent leadership, communication, and problem-solving skills, with the ability to guide teams in complex, global environments.

• Fluency in English and Spanish, both written and spoken.

Relocation benefits are not available for this position.

Who we are

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.

Roche is an Equal Opportunity Employer.