What You'll Do
Oversee end-to-end site management for complex clinical trials, ensuring patient safety and high-quality data collection in alignment with ICH-GCP and internal procedures. Conduct all phases of monitoring visits—qualification, initiation, routine, and close-out—on-site or remotely, and prepare detailed reports to document findings and actions.
Support audit preparedness by maintaining accurate Investigator Site Files and ensuring alignment with the Trial Master File. Guide sites on regulatory compliance, including IRB/EC submissions, informed consent processes, and essential document retention. Monitor investigational product handling, including storage, dispensing, and accountability, while safeguarding blinded data integrity.
Review clinical data for accuracy, resolve queries through EDC systems, and collaborate with data management teams to ensure completeness. Identify and report serious adverse events according to protocol, and assess risks related to protocol deviations or site performance, escalating as needed. Contribute to protocol development, monitoring plans, and training materials, and represent the team at sponsor and investigator meetings.
Mentor junior monitors, assist in staff training, and help maintain consistent monitoring standards across teams. Support investigator contracting and budget processes as directed, initiate investigator payments, and maintain strong relationships with site personnel to promote professional standards.
Requirements
- Bachelor’s degree or equivalent in a scientific, healthcare, or business-related field
- At least 3.5 years of hands-on, on-site monitoring experience, with a strong background in oncology trials
- Proven experience in global clinical trial operations
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
- Fluency in English, both written and verbal
- Demonstrated understanding of ICH-GCP, SOPs, and the drug development lifecycle
- Ability to travel frequently (60–70%) to trial sites as project demands
- Strong attention to detail and ability to maintain accuracy over extended periods
- Customer-focused approach with adaptability and teamwork
Benefits
Work within a scientifically driven organization focused on advancing therapies in oncology and rare diseases. Contribute to improving the efficiency and success of clinical development while upholding rigorous quality standards. Enjoy opportunities for professional growth, mentorship, and involvement in high-impact global trials.
Work Mode
This role requires regular travel (60–70%) and is based in Shanghai or Beijing. Candidates must be prepared for a mobile work schedule aligned with project needs.
