Clinical Trials Specialist

4 weeks ago


Beijing, Beijing, China Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Trials Specialist, you'll play a critical role in the management and preparation of Country Submissions in line with our global submission strategy.

Key Responsibilities:

  • Prepare, review, and coordinate local regulatory submissions (MoH, EC, and additional special national local applications) in alignment with our global submission strategy.
  • Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
  • Coordinate project-specific local SIA services and ensure alignment with submissions activities and timelines.
  • May have contact with investigators for submission-related activities.
  • Key-contact at country level for Ethical or Regulatory submission-related activities.
  • Coordinate with internal functional departments to ensure site start-up activities are aligned with submissions activities and timelines.
  • Achieve PPD's target cycle times for site.
  • May work with the start-up CRA(s) to prepare regulatory compliance review packages.
  • May develop country-specific Patient Information Sheet/Informed Consent form documents.
  • May assist with grant budgets and payment schedules negotiations with sites.
  • Support the coordination of feasibility activities in accordance with agreed timelines.
  • Enter and maintain trial status information onto PPD tracking databases in an accurate and timely manner.
  • Ensure local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs.
  • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Requirements:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years).
  • Effective oral and written communication skills.
  • Excellent interpersonal skills.
  • Strong attention to detail and quality of documentation.
  • Good negotiation skills.
  • Good digital literacy and the ability to learn appropriate software.
  • Good English language and grammar skills.
  • Basic medical/therapeutic area and medical terminology knowledge.
  • Ability to work in a team environment or independently, under direction, as required.
  • Basic organizational and planning skills.
  • Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations.


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