Job Description

Our Global Clinical Trial team is at the heart of advancing our clinical development portfolio, turning science into meaningful outcomes for patients. We are looking for a Clinical Research Manager (CRM) to drive the end-to-end execution of clinical studies in Brazil.

This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

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, Our 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.
• 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 Our Company with investigators
• Shares protocol-specific information and best practices across countries\clusters

Required Experience

• 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

Required:

• Bachelor degree in Science (or comparable)
• English Proficiency

Preferred:
Advanced degree, (e.g., Master degree, MD, PhD)

"Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros. Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificado."

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