Clinical Operations Associate

3 days ago

Beijing, Beijing, China Thermo Fisher Scientific Full time
Job Title: Clinical Operations Delivery Associate I

At Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Operations Delivery Associate I, you will play a critical role in supporting the delivery of clinical trials and ensuring the success of our customers.

Key Responsibilities:
  • Coordinate and oversee trial activities, ensuring timely completion and high-quality standards.
  • Perform file reviews, including department, internal, country, and investigator files, as assigned.
  • Ensure allocated tasks are performed on time, within budget, and to a high-quality standard, communicating any risks to project leads and line managers as necessary.
  • Support the maintenance of study-specific documentation and global support with specific systems, tools, and trackers.
  • Provide system support, including GoBalto and eTMF.
  • Support Risk-Based Monitoring (RBM) activities.
  • Perform administrative tasks, including timely processing of documents, performing eTMF reviews, and providing documents and reports to internal team members.
  • Support scheduling of client and/or internal meetings, including completion of related meeting minutes.
  • Review and track local regulatory documents.
  • Transmit documents to clients and centralized IRB/IEC.
  • Analyze and reconcile study metrics and findings reports, assisting with clarification and resolution of findings related to site documentation.
  • Maintain vendor trackers.
  • Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assist with study-specific translation materials and translation QC upon request.
Requirements:
  • Bachelor's degree preferred.
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
  • Ability to work in a team or independently as required.
  • Ability to handle multiple tasks efficiently.
  • Ability to analyze project-specific data/systems to ensure accuracy and efficiency.
  • Flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines.
  • Ability to attain and maintain a good understanding of applicable Country Regulations, ICH, and organization/Client SOPs and WPDs.
  • Strong English language and grammar skills and proficient local language skills as needed.
  • Strong IT skills, proficient in MS Office (Word, Excel, and PowerPoint), and ability to obtain knowledge and master all clinical trial database systems.
  • Ability to complete CRG clinical training program.

We are committed to creating a diverse and inclusive work environment that values diverse experiences, backgrounds, and perspectives. If you are passionate about making a difference in the lives of others and are looking for a challenging and rewarding career, we encourage you to apply for this exciting opportunity.

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