Study Start Up Specialist Exclusive PCD

Study Start Up Specialist Exclusive PCD page is loaded## Study Start Up Specialist Exclusive PCDlocations: Sao Paulotime type: Full timeposted on: Posted Todaytime left to apply: End Date: October 8, 2025 (13 days left to apply)job requisition id: 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**About Roche:**A healthier future. That’s what drives us to innovate. To continuously advance science and ensure that everyone has access to healthcare—today and for future generations. Creating a world where we all have more time with the people we love. That’s what makes us Roche.**Purpose, Objectives and Scope of 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 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 executing effective start-up strategies while maintaining regulatory compliance. Additionally, this role involves managing amendments throughout the study lifecycle. You will bring subject matter expertise and may work cross functionally in the following areas below:**Study Start Up Strategy & Execution:**Support and execute study start-up strategies for faster site activations, collaborating with internal and external teams, CROs, and sites. Help identify issues, follow regulations/SOPs, and assist with Health Authority/Ethics Committee communication. Track submissions in relevant systems and stay updated on regulatory requirements.**Informed Consent Form (ICF) Management:**Assist in preparing/adapting ICFs, supporting IRB/EC/HA submissions and changes, and archiving approvals.**Clinical Trial Submissions & Regulatory Coordination:** Prepare and manage submission packages for regulatory bodies and health authorities. Assist in responding to RFIs and ensure timely document submission to the TMF. Support study amendments and notifications.**Site Documentation & Compliance:** Collect and verify site documents (CVs, etc.). Assist with translations, patient materials, and biobank details. Learn local document needs and timelines. Support local vendors (excluding CROs) if needed.**Budgeting & Contract Management:** Provide assistance with contract negotiations & execution (confidentiality, indemnity, amendments). Collaborate with internal/external partners on financial/legal compliance. Help update contract system data for planning.**Payment Oversight:** Assist in overseeing site payments, escalations, and reporting via shared service centers and in compliance with site contracts. Help ensure financial/regulatory compliance for local operations. Participate in accrual/purchase order planning and reconciliation.**Qualifications**● Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable**Skills and Competencies**● Fluency in written and spoken English is mandatory. ● Fluency in written and spoken language(s) of the host country is mandatory.**Relocation benefits are not available for this position.****This position is exclusively for people with disabilities (PCD)**# Who we areA 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.**
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