Clinical Affairs Supervisor (IVD/CDx)

Location: Shanghai, China

Company

hirify.global partners with customers globally to develop science and technology solutions that address complex challenges.

What you will do

• Develop clinical evidence strategies for clinical evaluations, study design, overseas clinical data analysis, and submissions.
• Write clinical trial protocols and define standard operating procedures, monitoring plans, case report forms, and related study documentation.
• Plan, implement, manage, and interpret clinical trials across multiple product lines.
• Manage project budgets and resources, establish clinical sites, and maintain relationships with investigators and key opinion leaders.
• Organize investigator meetings and prepare clinical data analyses, presentations, reports, and publication contributions.
• Lead trial quality control and collaborate with internal functions and external partners throughout product development.

Requirements

• Experience in clinical affairs, clinical evaluation, and clinical trial development.
• Ability to manage registrational clinical trials and multiple product-line projects.
• Knowledge of IVD and CDx clinical trial requirements and NMPA regulations.
• Experience collaborating with biostatistics, data management, regulatory, quality, R&D, investigators, consultants, contractors, and Contract Research Organizations.
• Ability to lead clinical trial development, perform co-monitoring, and maintain trial quality standards.

Culture & Benefits

• Opportunity to contribute to the real-life impact of science and technology.
• Use of hirify.global Business System tools to develop and improve global clinical affairs standard work processes.
• Cross-functional and external collaboration across global product development activities.