Clinical research manager – São Paulo/SP

Responsabilidades

• 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, quality standards and adverse event reporting requirements internally and externally, and with policies and procedures of a empresa.
• 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 other local roles in the protocol, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles ensuring 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.
• 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 a empresa with investigators.
• Shares protocol-specific information and best practices across countries/clusters.

Requisitos

• QUALIFICAÇÕES MÍNIMAS
  • Bachelor degree in Science (or comparable).
  • English Proficiency.
  • Proven hands-on experience in end-to-end management of sponsor-led Phase I–III clinical trials, beyond site monitoring activities.
  • Experience managing large-scale and/or highly complex clinical trials, including megatrials.
  • Experience with complex study designs and operational models, with greater emphasis on study type, scale and complexity than on a specific therapeutic area.
  • Strong knowledge of ICH-GCP, clinical research regulations and quality standards.
  • Strong project management, risk management and cross-functional stakeholder management capabilities.
  • Clinical Data Management, Clinical Research, Clinical Site Management, Clinical Trial Management, Good Clinical Practice (GCP), Risk Based Monitoring, Strategic Planning, Strategic Thinking, Vendor Management.
• QUALIFICAÇÕES PREFERENCIAIS
  • Advanced degree, (e.g., Master degree, MD, PhD).

Marcado como: Compliance, Controle de Qualidade, Estudos Clínicos, Gestão de Projetos, Gestão de Riscos, Indústria Farmacêutica, Pesquisa Clínica