Clinical Start-Up
4 semanas atrás
Position Summary The Clinical Start-Up & Trial Lead (Start-Up CTL) is responsible for the strategic planning coordination and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site initiation through to study close-out serving as the primary operational point of contact for internal teams vendors and clinical sites. Key Responsibilities Start-Up Responsibilities Lead country / site feasibility site selection and activation strategy in collaboration with project teams. Oversee development and negotiation of site contracts budgets and regulatory / ethics submissions. Track and report on start-up timelines metrics and bottlenecks; drive resolution. Collaborate with Regulatory Legal and Contracts to ensure timely delivery of activation packages. Ensure readiness for site initiation visits (SIVs) and coordinate site training. Clinical Trial Lead Responsibilities Provide end-to-end operational oversight for the assigned study(ies) including CRO / vendor and site performance. Lead cross-functional study team meetings and act as key escalation point for site-level issues. Monitor overall study progress timelines and quality metrics; implement mitigation plans as needed. Drive proactive risk identification and resolution aligning with RBQM principles. Ensure inspection-readiness through quality oversight of TMF monitoring reports and issue management. Partner with data management medical and safety teams to ensure clean timely data delivery. Qualifications Education & Experience Bachelors degree in life sciences or a related field; advanced degree preferred. 6 years of clinical research experience including significant site start-up and CTL / project management responsibilities. Prior experience in a CRO biotech or pharma environment required. Strong knowledge of ICH GCP regulatory requirements and clinical trial lifecycle. Skills & Competencies Proven ability to manage multiple timelines and priorities with attention to detail. Strong project leadership and stakeholder engagement skills. Familiarity with EDC CTMS eTMF and site start-up platforms (e.g. Veeva Vault Medidata). Excellent communication negotiation and team-building skills. Solution-oriented mindset and comfort with ambiguity in fast-paced environments. Travel Requirements Up to 20% domestic and / or international travel as needed. Why Join Us We offer a dynamic environment where innovation accountability and integrity are this dual-role position youll have an opportunity to shape trial success from the very beginning and carry that leadership throughout the study lifecycle. Learn more about our EEO & Accommodations request here . Key Skills Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture Employment Type: Full-Time Experience: years Vacancy: 1 #J-18808-Ljbffr
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Clinical Start-Up
4 semanas atrás
São Paulo, Brasil Fortrea Tempo inteiroPosition SummaryThe Clinical Start-Up & Trial Lead (Start-Up CTL) is responsible for the strategic planning coordination and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site initiation through to study close-out serving as the primary operational...
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Clinical Start-Up
4 semanas atrás
São Paulo, Brasil Fortrea Tempo inteiroPosition SummaryThe Clinical Start-Up & Trial Lead (Start-Up CTL) is responsible for the strategic planning coordination and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site initiation through to study close-out serving as the primary operational...
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Study Start Up Lead
2 semanas atrás
São Paulo, Brasil F. Hoffmann-La Roche Ag Tempo inteiroAt 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 and respected for who you are, allowing you to thrive both personally and professionally. Join Roche, where every voice matters. Study Start up Lead (SSUL) – location:...
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Study Start up Lead
3 semanas atrás
São Paulo, Brasil Roche Tempo inteiro1 day ago Be among the first 25 applicants 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...
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Clinical Site Navigator
Há 4 dias
São Paulo, Brasil Fortrea Tempo inteiroThe Clinical Site Navigator role is a hybrid position that combines start-up and iHCRA/CRA responsibilities. Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical trial and potentially through closeout activities as required. Serving as the single point of contact for...
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Study Start Up Manager
3 semanas atrás
São Paulo, Brasil Medpace Tempo inteiroOverview Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo! This position plays a key role in the study start up process at Medpace. Responsibilities Efficiently manage and successfully execute all aspects of global...
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Study Start up Lead
3 semanas atrás
São Paulo, Brasil F. Hoffmann-La Roche AG Tempo inteiroStudy Start up Lead (SSUL) page is loaded## Study Start up Lead (SSUL)locations: Sao Paulotime type: Full timeposted on: Posted Todaytime left to apply: End Date: December 8, 2025 (6 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...
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Study Start up Lead
3 semanas atrás
São Paulo, Brasil F. Hoffmann-La Roche Gruppe Tempo inteiroAt 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...
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Study Start Up Lead
2 semanas atrás
São Paulo, Brasil F. Hoffmann-La Roche Gruppe Tempo inteiroAt 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...
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Study Start Up Manager
2 semanas atrás
São Paulo, Brasil Medpace Tempo inteiroOverview Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo! This position plays a key role in the study start up process at Medpace. If you want an exciting career where you use your previous expertise and can develop and...
