Study Start Up Lead (SSUL)

RocheSao PauloonsiteSalary not postedView the original posting 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 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: ● 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: ● Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and bestpractices 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,

The people who work here are one introduction away.

We show you who they are and write your first message — the insider list for this posting is filling in now. You have one introduction. The rest follows.

People at Roche you can reach out to

7 of 59 public LinkedIn profiles found in searches for Roche list Roche in their headline — those are the ones you can be confident work there. Pick who to reach out to — we'll draft your message; you make the contact. The rest, when shown, are marked Unverified.

Profiles are public pages as indexed by the search engine — we never log in to LinkedIn or copy private data, and anyone can ask to be removed. Ask to be removed →

Start the conversation More Study start-up jobs