Clinical Trials Specialist

2 weeks ago

Beijing, Beijing, China Thermo Fisher Scientific Full time
Unlock Your Potential as a Trial Activation Approval Specialist II

At Thermo Fisher Scientific, we're committed to empowering our customers to make the world a healthier, cleaner, and safer place. As a Trial Activation Approval Specialist II, you'll play a vital role in bringing our mission to life by ensuring the smooth execution of clinical trials.

Key Responsibilities:
  • Prepare, review, and coordinate local regulatory submissions, including MoH, EC, and special national applications, in alignment with our global submission strategy.
  • Provide local regulatory strategy advice to internal clients, under mentorship.
  • Coordinate project-specific local SIA services and ensure alignment with submission activities and 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 and timelines.
  • Achieve PPD's target cycle times for site activation.
  • May work with start-up CRAs 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, as required, 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.
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.

We're committed to creating a workplace where diverse experiences, backgrounds, and perspectives are valued. Join us in accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific.

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