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Clinical Operations Associate Manager

Há 1 mês

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

About the Role

The Associate Manager, Clinical Operations is a key position within Kenvue's Clinical Operations team, responsible for coordinating the study management operational aspects for Higher complexity clinical studies for regional and/or global projects for Consumer Health products.

Key Responsibilities

  • Lead all operational aspects of assigned clinical studies in accordance with ICH GCP guidelines, company standard operating procedures, and local regulations.
  • Ensure that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure subject safety, data quality and accurate study timelines, budgets and quality standards are met.
  • Participate in and coordinate the selection/evaluation/setup of external service providers (ESPs) (e.g., study sites, investigators, etc.) including execution of quality/security assessments, confidentiality agreements, healthcare compliance submissions, clinical trial agreements, and purchase orders, in cooperation with Healthcare Compliance, Quality & Compliance, Information Security Risk Management, and Contracting teams.
  • Serve as the primary point of contact with selected ESPs and train site personnel on study-specific protocol procedures and overall general Kenvue requirements.
  • Collaborate under the direction of Clinical Operations Study Management Leads globally who will provide study operational delivery strategy and guide on critical study elements.
  • Prepare and/or review/approve study-specific essential documents including informed consent forms (ICFs), training materials, source documents, case report forms (CRFs), statistical analysis plans, recruiting materials, etc.As needed, coordinate the translation of study-specific documents and the procurement of appropriate license agreements.
  • Oversee preparation and clinical release of investigational and auxiliary products, including determining required quantities, approving clinical label copies, overseeing development of reference safety materials, and ensuring accountability and final disposition of the products.
  • Ensure Sponsor oversight by monitoring the progress of studies and the performance of ESPs on a continual basis through review/preparation of monitoring plans/reports, ongoing communication with the ESPs, review of clinical listings and logs, and routing/resolution of queries.
  • Identifies and raises study-related issues and deviations to study team and senior management. Participates in the generation of corrective and preventative action plans
  • Ensure that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs), and Pregnancies are reported within required reporting timelines and documented/processed appropriately.
  • Set-up and maintain the Trial Master File (TMF) in real time following internal procedures.
  • Coordinate and lead clinical trial disclosures on public registries, as needed.
  • Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.
  • Write and review of Clinical Study Reports, ensuring they are written and approved within required timelines.
  • Provides administrative and technical support to the junior Study Managers
  • Provides administrative support for site activation activities.
  • Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.

Requirements

  • Minimum of a bachelor's degree in Science, Nursing, or related field.
  • Experience as an independent Clinical Study Manager (or equivalent role) including, but not limited to, experience with protocol development, informed consent form, and other essential clinical documents and electronic trial master file (TMF) management.
  • In-depth knowledge of electronic trial master file (TMF) management and clinical trial management system (CTMS)
  • Demonstrated working knowledge of cosmetic and drug regulations globally
  • Advanced English is required (spoken and written).
  • Excellent written and verbal communication and presentation skills, in English.
  • Flexible attitude and ability to work with global study teams in an agile environment.
  • Excellent attention to detail.
  • Good problem-solving and critical thinking skills.
  • Efficient, organized, and capable of prioritizing multiple tasks.
  • Proficiency in ICH GCP regulations/guidelines.
  • Proficiency in Microsoft applications including Outlook, Word, Excel, Teams, PowerPoint, and Adobe.
  • Good interpersonal relationship skills and being able to work effectively in cross-functional teams both internally and externally to the organization.
  • Willingness to adapt to changing priorities and assignments.

Preferred Qualifications

  • CCRP or equivalent certification.
  • Experience as a Clinical Study Manager in global drug clinical studies.