Clinical Research Scientist II

2 meses atrás


São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiro

Position Overview

Kenvue is seeking a qualified candidate for the role of:

Scientist II, Clinical Operations

This role is integral to our operations and focuses on managing clinical studies for our Consumer Health products.

About Kenvue

At Kenvue, we harness the remarkable potential of everyday care. With a legacy spanning over a century and a foundation in scientific innovation, we proudly represent renowned brands such as NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S, and BAND-AID. Our commitment to science and care drives us to deliver exceptional products to our customers. Our diverse team of 22,000 dedicated individuals is passionate about insights and innovation, empowering us to positively impact millions of lives daily.

Key Responsibilities

  • Manage clinical studies in alignment with ICH GCP guidelines, company protocols, and local regulations.
  • Ensure compliance with study protocols and contractual agreements to safeguard subject safety and maintain data integrity.
  • Coordinate the selection and evaluation of external service providers, ensuring quality assessments and compliance with healthcare regulations.
  • Act as the primary liaison with external service providers, providing training on study protocols and Kenvue requirements.
  • Collaborate with Clinical Operations Study Management Leads to develop operational strategies for studies.
  • Prepare essential study documents, including informed consent forms and training materials, and coordinate translations as necessary.
  • Oversee the preparation and clinical release of investigational products, ensuring accountability and compliance.
  • Monitor study progress and external service provider performance, addressing any issues that arise.
  • Ensure timely reporting of adverse events and maintain accurate documentation.
  • Establish and maintain the Trial Master File in real-time according to internal procedures.
  • Review and approve vendor invoices to ensure compliance with contracts and budgets.
  • Contribute to the writing and review of Clinical Study Reports, ensuring timely completion.

Qualifications

Required Qualifications

  • Bachelor's degree in Science, Pharmacy, Chemistry, Biomedical Science, Engineering, or related fields.
  • Experience as a Clinical Study Manager or in a similar role, with expertise in protocol development and trial master file management.
  • Proficient in English, both spoken and written.
  • Ability to work collaboratively with global teams in a dynamic environment.
  • Strong attention to detail and organizational skills, capable of managing multiple priorities.
  • Proficient in Microsoft Office applications.
  • Excellent interpersonal skills and the ability to work effectively in cross-functional teams.
  • Willingness to adapt to changing priorities and travel as needed.

Location

Latin America-Brazil-São Paulo

Job Function

Research and Development



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