Clinical Study Lead

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Data de término: 8 de janeiro de 2026 (13 dias restantes para se candida tar) job requisition :
Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretend emos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras.

Junte-se à Roche, onde cada voz é importante.### A posiçãoThe role focuses on the responsibilities to ensure leadership and execution of one or more sponsored interventional trials or managed primary data collection non-interventional studies, the effective and efficient delivery of all operational aspects in accordance with the appropriate quality standards including ICH/GCP and GVPs/GPPs.
** Your Responsibilities
*** Ensures study adherence to appropriate guidelines (ICH GCP/GVP/GPP), relevant regulations and Roche procedural documents. Ensures study inspection readiness at all times. Ensures the completion and finalization of any corrective and preventive action plans resulting from site audits and inspections
* Provides operational input and insights into the development of study protocols, Clinical Study Reports, informed consent form and protocol feasibility questionnaires
* Promotes operational excellence. Oversees the delivery and maintenance of essential study plans and systems (e.g. site & country selection and monitoring plan; study tracking systems, clinical supply; vendor oversight plan; RBQM or equivalent risk management activities). Ensures accurate tracking and reporting of study metrics
* Chairs Study Management Team  meetings and organizes the investigator meetings and study kick-off meetings
* Establishes and maintains study budgets and approves invoices, identifies and communicates any issues/variances with study budgets and action plans for resolution
* Accountable for all vendor related operational study deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Leads vendor selections by reviewing proposals and providing recommendations, reviews and negotiates clinical work orders. Maintains oversight of vendor performance, issues, and their resolution and identifies systematic issues and coordinates any corrective action. Ensures vendors receive appropriate training.
* Ensures proper handling of all study close out activities including but not limited to the site close out, final drug accountability, final safety reconciliation and Inspection readiness of Trial Master File documentation.
** Who you are
*** Strong leadership skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies.
* Proven strategic capabilities, organizational awareness and proactive planning with embedded contingencies and risk management mindset.
* Clear understanding and experience applying ICH/GCP and/or GVP/GPPs and applicable regulations including awareness of quality requirements.
* Well-developed written and verbal communication skills demonstrated by an ability to present clear instructions/directions, to motivate your team, negotiate with peers and partners and influence cross functionally.
* Excellent problem solving, negotiation and conflict resolution skills
* Borderless

Collaboration:

working closely with other countries/communities/teams, embracing the loop of ‘sharing and learning together’ to co-create Solutions
* Budget Management-  cost effective management with limited unforeseen cost overruns.### Quem nós somos

Um futuro mais saudável nos leva a inovar. Juntos, mais de 100 mil funcionários em todo o mundo se dedicam ao avanço da ciência, garantindo que todos tenham acesso à saúde hoje e nas próximas gerações. Nossos esforços resultam em mais de 26 milhões de pessoas tratadas com nossos medicamentos e mais de 30 bilhões de testes realizados usando nossos produtos de diagnóstico.

Nós nos capacitamos para explorar novas possibilidades, promover a criatividade e manter as nossas ambições altas, para fornecer soluções de saúde que mudem a vida e causem um impacto global.

Vamos construir juntos um futuro mais saudável.
** A Roche é um empregador que pratica políticas de igualdade de oportunidades.*
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