Study Start Up Lead (SSUL)

F. Hoffmann-La Roche AG; São Paulo; On-site; BRL 320,000 - 520,000; Full time

Job summary

Roche is seeking a capable leader to drive study start-up strategies for country-level clinical trials in Brazil. You will oversee regulatory submissions, site activation, and cross-functional coordination with global teams and CRO partners.

The role requires strong ICH-GCP knowledge, vendor management, and fluent English, enabling effective collaboration across matrixed teams and multiple therapeutic areas.

Qualifications

• Degree in life sciences or equivalent; postgraduate degree desirable.
• Experience in clinical trial start-up, regulatory submissions, cross-functional collaboration.
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.

Responsibilities

• Lead country study start-up strategy and execution, drive efficiency and regulatory compliance.
• Oversee start-up operations, site activation, and alignment with global timelines.
• Develop and manage clinical trial submissions, amendments, and regulatory coordination.
• Manage site documentation, vendor interactions, and translation/approval of materials.
• Collaborate with CROs and internal teams to harmonize systems and improve timelines.

Skills

Excellent communication

Leadership/People management

Regulatory knowledge

Cross-functional collaboration

Attention to detail

English fluency

Education

MD/PhD/MA/MS in life sciences

Tools

Veeva Vault

CTIS

RIM

Job description

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.

Key Responsibilities:

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.

Key responsibilities include:

• 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.
• 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). You will lead in a cross functional environment in multiple of the following areas

below: Study Start-Up Strategy & Execution:

Study Start-Up Strategy & Execution:

• Lead teams in the creation of the study start-up strategy and execution of the stud 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:

Informed Consent Form (ICF) Management:

• Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and bestpractices Clinical Trial Submissions & Regulatory

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.

If you are a People Leader (People Manager) in addition to the expectations outlined in this document you will also:

• Provide coaching, support and leadership, as part of the Roche Leadership Framework, to a group of direct reports. By exemplifying our Roche values, Leadership commitments and modeling our Roche Operating Principles, you will ensure we achieve our ambitions for our people and patients.
• Conduct a regular year-round assessment of performance, contributions, and impact and provide feedback, coaching, and performance management.
• Lead by example in demonstrating and championing inclusive behaviours in your team, PDG, PD, and the Roche Enterprise. Provide opportunities for growth and development for all team members and address any barriers that may exist.
• People management-related administration (e.g. Workday People & Culture Management system tasks) and contact for employment-related matters.

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 PLs)

Skills & Competencies

• Excellent communication and interpersonal skills
• Strong organizational, analytical, and problem-solving capabilities
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)
• Collaborative and adaptable mindset with attention to detail
• Ability to lead through complexity and ambiguity, especially in matrixed and global teams
• Fluency in written and spoken English is mandatory.
• Fluency in written and spoken language(s) of the host country is mandatory.

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.