Clinical Trials Specialist II

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 a healthier, cleaner, and safer place. As a Clinical Trials Specialist II, you'll play a critical role in bringing our mission to life by participating 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 mutually agreed-upon timelines.
  • May have contact with investigators for submission-related activities.
  • Key-contact at the 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 mutually agreed-upon timelines.
  • Achieve PPD's target cycle times for site.
  • May work with the start-up CRA(s) to prepare regulatory compliance review packages, as applicable.
  • 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, as required, in accordance with agreed timelines.
  • Enter and maintain trial status information relating to SIA activities 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 the 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.

We're committed to accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need. Join us in making a positive impact on a global scale.

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