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Clinical Operations Specialist

1 month ago

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Job Title: Clinical Operations Associate

Job Summary:

We are seeking a highly skilled Clinical Operations Associate to join our team at Kenvue. As a Clinical Operations Associate, 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, company standard operating procedures, and local regulations.

Key Responsibilities:

  • Lead all operational aspects of assigned clinical studies from protocol development through study report finalization 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.
  • Collaborate with a cross-functional team on study design development.
  • Serve as lead for protocol development (based on a protocol synopsis created by the Study Director) in collaboration with internal and external stakeholders.
  • 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.
  • 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.
  • 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.
  • Identify and raise study-related issues and deviations to study team and senior management. Participate 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.
  • Contribute to the writing and review of Clinical Study Reports, ensuring they are written and approved within required timelines.

Qualifications:

  • Minimum 3 years of experience as an independent Sponsor Clinical Study Manager or (or equivalent role) including, but not limited to, experience with protocol development, informed consent form, and other essential documents.
  • 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/China 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.

Desired Qualifications:

  • GCP or equivalent certification.
  • Demonstrated working knowledge of regulations.
  • Experience with TMF Reference Model.

Primary Location: Asia Pacific-China-Shanghai-Shanghai

Job Function: Clinical Trial Administration