Country Study Start up Team Leader

Roche; México; Presencial; MXN 736,000 - 1,105,000; Jornada completa

Descripción de la vacante

A leading global healthcare firm is seeking a professional to drive efficient clinical trial start-up processes. The successful candidate will collaborate with various teams to ensure seamless trial execution while managing regulatory compliance and site activation. A relevant life sciences degree and a proven background in clinical trial start-up are essential. Strong leadership and fluency in English and the local language are mandatory. This position does not offer relocation benefits.

Formación

• Fluency in written and spoken English is mandatory.
• Fluency in written and spoken language of the host country is mandatory.
• Demonstrated experience in regulatory environments.

Responsabilidades

• Lead study start-up strategy and execution.
• Oversee informed consent form (ICF) management.
• Manage clinical trial submissions and regulatory coordination.
• Strategically manage site documentation and compliance.
• Provide oversight for budgeting and contract management.
• Oversee payment processes and ensure compliance.

Conocimientos

Clinical trial start-up

Regulatory submissions

Cross-functional collaboration

Vendor/CRO relationship management

Leadership

Educación

Degree in life sciences

Postgraduate or master's degree

Descripción del empleo

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.

The Position

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.
• 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).

Responsibilities

• You will lead in a cross functional environment in multiple of the following areas below:
• Study Start-Up Strategy & Execution: Lead teams in the creation of the study start-up strategy and execution of the study start-up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners.
• Informed Consent Form (ICF) Management: Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices
• Clinical Trial Submissions & Regulatory Coordination: Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.
• Site Documentation & Compliance: Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed. Oversee translation and approval of drug labels and patient-facing materials, as required. Maintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs
• Budgeting & Contract Management: Provide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value-based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity/insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting
• Payment Oversight: Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.

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
• 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

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.