Clinical Research Monitor

4 weeks ago

Beijing, Beijing, China Thermo Fisher Scientific Full time
Job Summary

As a Clinical Research Monitor at Thermo Fisher Scientific, you will play a critical role in ensuring the success of our clinical trials. Your primary responsibility will be to monitor and coordinate the clinical monitoring and site management process, ensuring compliance with regulatory requirements and company protocols.

Key Responsibilities
  • Conduct remote or on-site visits to assess protocol and regulatory compliance, and manage required documentation.
  • Manage procedures and guidelines from different sponsors and/or supervising environments, ensuring that trial sites are in compliance with approved protocols, ICH-GCP guidelines, and applicable regulations.
  • Act as a site processes specialist, ensuring that trials are conducted in accordance with approved protocols, ICH-GCP guidelines, and applicable regulations, guaranteeing subject rights, well-being, and data reliability.
  • Develop collaborative relationships with investigational sites, ensuring effective communication and coordination.
  • Conduct supervising tasks in accordance with the approved monitoring plan, ensuring that trial sites are in compliance with regulatory requirements.
Requirements
  • Bachelor's degree in a life sciences-related field or equivalent and relevant formal academic/vocational qualification.
  • Previous experience in clinical research monitoring, with a proven track record of success in ensuring compliance with regulatory requirements and company protocols.
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
  • Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate root cause analysis, and problem-solving.
  • Ability to manage Risk-Based Monitoring concepts and processes.
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
  • Ability to maintain customer focus through good listening skills, attention to detail, and the ability to perceive customers' underlying issues.
  • Good organizational and time management skills.
  • Effective interpersonal skills.
  • Attention to detail.
  • Ability to remain flexible and adaptable in a wide range of scenarios.
  • Ability to work in a team or independently as required.
  • Good digital literacy, with solid knowledge of Microsoft Office and the ability to learn appropriate software.
  • Good English language and grammar skills.
  • Good presentation skills.
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.

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