Clinical Operations Lead

1 month ago

Shanghai, Shanghai, China Kenvue Full time
Clinical Operations Lead

Estimated Salary: $120,000 - $180,000 per year

About the Role:

We are seeking a highly skilled Clinical Operations Lead to join our team at Kenvue. As a key member of our clinical operations team, you will be responsible for leading all operational aspects of assigned clinical studies from protocol development through study report finalization in accordance with ICH GCP guidelines and local regulations.

Key Responsibilities:
  • Lead all operational aspects of assigned clinical studies, including protocol development, informed consent form creation, and essential document preparation.
  • Ensure that all clinical trials are conducted in compliance with the study protocol and contractual agreements, ensuring subject safety, data quality, and accurate study timelines, budgets, and quality standards.
  • Collaborate with cross-functional teams on study design development and oversee the selection/evaluation/setup of external service providers (ESPs).
  • Serve as the primary point of contact with selected ESPs and train site personnel on study-specific protocol procedures and overall Kenvue requirements.
  • Prepare and review/approve study-specific essential documents, including informed consent forms, training materials, source documents, case report forms, statistical analysis plans, and recruiting materials.
Qualifications:
  • Minimum 3 years of experience as an independent Sponsor Clinical Study Manager or equivalent role, including experience with protocol development, informed consent form creation, and other essential documents.
  • Advanced English is required (spoken and written), with excellent written and verbal communication and presentation skills.
  • 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, and 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.
Location:

Asia Pacific-China-Shanghai

Job Function:

Clinical Trial Administration

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