Clinical Trials Specialist

1 month ago

Beijing, Beijing, China Thermo Fisher Scientific Full time
Support the Preparation and Coordination of Clinical Trials

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 supporting the preparation and coordination of clinical trials, ensuring that our customers receive the highest quality services.

Key Responsibilities:
  • Prepare, review, and coordinate local EC submissions in alignment with global submission strategy.
  • Support the preparation of local Moho submissions, as applicable, in alignment with global submission strategy.
  • Coordinate with internal functional departments to ensure site start-up activities are aligned with submissions activities and mutually agreed-upon timelines.
  • Ensure alignment of submission process for sites and study with the critical path for site activation.
  • Meet PPD's target cycle times for site activation.
  • May have contact with investigators for submission-related activities.
  • May act as a key-contact at the country level for either Ethical or Regulatory submission-related activities.
  • Work with start-up CRA(s) to prepare regulatory compliance review packages, as applicable.
  • Assist in developing country-specific Patient Information Sheet/Informed Consent form documents.
  • Assist with grant budgets and payment schedules negotiations with sites.
  • Enter and maintain trial status information relating to SIA activities onto PPD or client 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 0 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.
What We Offer:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

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