Scientist II, Clinical Operations Specialist

2 meses atrás

São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiro
Scientist II, Clinical Operations

Kenvue is a leading global healthcare company that is passionate about delivering innovative solutions to improve people's lives. We are currently seeking a highly skilled Scientist II, Clinical Operations to join our team.

About the Role

The Scientist II, Clinical Operations will be responsible for managing clinical operations activities, including study management, site qualification, and monitoring. This role will also involve collaborating with cross-functional teams to ensure the successful execution of clinical trials.

Key Responsibilities

  • Manage clinical studies in accordance with ICH GCP guidelines and company standard operating procedures.
  • Ensure that all clinical trials are conducted in compliance with the study protocol and contractual agreements.
  • Participate in the selection and evaluation of external service providers, including study sites and investigators.
  • Train site personnel on study-specific protocol procedures and Kenvue requirements.
  • Collaborate with Clinical Operations Study Management Leads to ensure study operational delivery strategy and guide on critical study elements.
  • Prepare study-specific essential documents, including informed consent forms, training materials, and case report forms.
  • Oversee the preparation and clinical release of investigational and auxiliary products.
  • Ensure Sponsor oversight by monitoring the progress of studies and the performance of external service providers.
  • Identify and raise study-related issues and deviations to the study team and senior management.
  • Ensure that all Adverse Events, Serious Adverse Events, Product Quality Complaints, and Pregnancies are reported within required reporting timelines and documented/processed appropriately.
  • Set-up and maintain the Trial Master File in real time following internal procedures.
  • Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.

Requirements

  • Minimum of a bachelor's degree in Science, Pharmacy, Chemistry, Biomedical Science, Engineering, or related fields.
  • Experience as an independent Clinical Study Manager, including protocol development, informed consent form, and electronic trial master file management.
  • Advanced English is required (spoken and written).
  • Flexible attitude and ability to work with global study teams and external service providers in an agile environment.
  • Excellent attention to detail, efficient, organized, and capable of prioritizing multiple tasks.
  • Proficiency in Microsoft applications, including Outlook, Word, Excel, Teams, PowerPoint, and Adobe.
  • Good interpersonal relationship skills and ability to work effectively in cross-functional teams both internally and externally to the organization.
  • Willingness to adapt to changing priorities and assignments.
  • Willingness to travel up to 10% of time.

Primary Location

Latin America-Brazil-São Paulo-São José dos Campos

Job Function

R&D

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