Clinical Start-up
1 semana 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**- Bachelor’s 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 valued. In this dual-role position, you'll 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.
-
Clinical Start-Up
2 semanas atrás
São Paulo, 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...
-
Clinical Start-Up
1 semana 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...
-
Clinical Start-up
1 semana atrás
São Paulo, Brasil Fortrea Tempo inteiro**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...
-
Clinical Start-Up
1 semana atrás
São Paulo, Brasil Fortrea Tempo inteiroPosition 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...
-
Clinical Start-Up
1 semana 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...
-
Study Start Up Lead
4 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:...
-
Study Start-up Associate Ii
2 semanas atrás
São Paulo, Brasil ICON Plc Tempo inteiroSSUA II ANVISA - Office Based - São PauloICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Study Start Up Associate II to...
-
São Paulo, Brasil Astrazeneca Tempo inteiroRegulatory & Start Up Manager (Clinical Trials/Brazil) Astrazeneca•São Paulo, Brasil Descrição da vaga Você está pronto(a) para liderar uma equipe dedicada a transformar a ciência inovadora em soluções tangíveis para pacientes com necessidades médicas não atendidas? Estamos procurando um Gerente de Start-up e Regulatório em Oncologia para se...
-
Sr Clinical Site Navigator
Há 6 dias
São Paulo, Brasil Fortrea Tempo inteiroJob Overview The 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...
-
Sao Paulo, Brasil Medpace, Inc. Tempo inteiroJob Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Study Start-Up Manager (Regulatory Submissions Manager) to support our growing Study Start-Up/Regulatory Submissions team at Medpace! This position plays a key role in the clinical trial management process at Medpace. If you want an...
