Vaga de parceiro

Clinical Research Manager - São Paulo / SP

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Detalhes da Vaga

  • Escolaridade Não Informado
  • Segmento Não Informado
  • Salário Não Informado
  • Área de AtuaçãoDiversos / Outros

O que você irá fazer

  • For certain studies, the CRM could be responsible for several countries in a cluster.
  • Responsibilities include, but are not limited to:Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
  • Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
  • Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
  • Performs Quality control visits as required.
  • Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
  • Responsible for creating and executing a local risk management plan for assigned studies.
  • Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
  • Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate).
  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
  • Country POC for programmatically outsourced trials for assigned protocols.
  • Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).
  • Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies.
  • GHH to be consulted as needed.
  • As a customer-facing role, this position will build business relationships and represent company with investigators.
  • Shares protocol-specific information and best practices across countries/clusters.
  • Experience Requirements:Solid experience with Clinical Research management and desirable experience in immunology study.
  • Solid previous experience as CRA monitoring clinical trials.
  • Educational Requirements:Bachelors degree in Science.
  • Preferred:Advanced degree, (e.
  • G.
  • BA/BS or higher) with a strong emphasis in science and/or biology.
  • Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: No Travel RequiredFlexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoJob Posting End Date: 04/23/2025Requisition ID: R344533#J-18808-Ljbffr

Informações Adicionais

  • Quantidade de Vagas 1
  • Jornada Não Informado
 

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