Clinical Operations Associate Manager

2 semanas atrás

Brasília, Distrito Federal, Brasil Kenvue Inc Tempo inteiro

About Kenvue

At Kenvue, we harness the remarkable potential of everyday care. With a legacy spanning over a century and grounded in scientific innovation, we proudly represent a portfolio of renowned brands, including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S, and BAND-AID.

Position Overview - Associate Manager, Clinical Operations

The Associate Manager, Clinical Operations plays a pivotal role in orchestrating the operational facets of complex clinical studies for regional and global initiatives focused on Consumer Health products, which encompass categories such as Baby, Face, Body, Sun Care, and Self Care. This position is essential for advancing product development and substantiating claims.

Key Responsibilities

  • Oversee all operational elements of assigned clinical trials, ensuring adherence to ICH GCP guidelines, internal standard operating procedures, and applicable local regulations.
  • Guarantee compliance with study protocols and contractual agreements to uphold subject safety, data integrity, and adherence to timelines, budgets, and quality benchmarks.
  • Engage in the selection, evaluation, and setup of external service providers (ESPs), including the execution of quality assessments, confidentiality agreements, and clinical trial agreements.
  • Act as the primary liaison with selected ESPs, providing training to site personnel on study-specific protocols and Kenvue's requirements.
  • Collaborate with Clinical Operations Study Management Leads globally to establish operational delivery strategies and address critical study components.
  • Prepare, review, and approve essential study documents, including informed consent forms, training materials, and statistical analysis plans.
  • Manage the preparation and clinical release of investigational products, ensuring accurate quantities and compliance with labeling and safety materials.
  • Monitor study progress and ESP performance, identifying and escalating study-related issues to the study team and senior management.
  • Ensure timely reporting and documentation of Adverse Events (AEs), Serious Adverse Events (SAEs), and Product Quality Complaints (PQCs).
  • Establish and maintain the Trial Master File (TMF) in real-time, adhering to internal protocols.
  • Coordinate clinical trial disclosures on public registries as necessary.
  • Track vendor invoices against key deliverables, ensuring compliance with contracts and study budgets.
  • Draft and review Clinical Study Reports, ensuring timely completion and approval.
  • Provide administrative and technical support to junior Study Managers and assist with site activation activities.
  • Contribute to the development of critical paths for site activation within assigned projects.

Qualifications

Required:

  • Bachelor's degree in Science, Nursing, or a related field.
  • A minimum of 5 years of experience in a Clinical Study Manager role or equivalent.
  • Comprehensive knowledge of electronic trial master file (TMF) management and clinical trial management systems (CTMS).
  • Proficient understanding of global cosmetic and drug regulations.
  • Advanced proficiency in English, both spoken and written.
  • Exceptional communication and presentation skills in English.
  • Adaptability to work with global study teams in a dynamic environment.
  • Strong attention to detail and problem-solving abilities.
  • Organized and capable of managing multiple priorities effectively.
  • Proficient in ICH GCP regulations and Microsoft applications.
  • Strong interpersonal skills and a willingness to adapt to changing priorities.

Desired:

  • CCRP or equivalent certification.
  • Experience managing global drug clinical studies.

Kenvue is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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