Clinical Affairs Supervisor

Clinical evidence strategy – Provides clinical strategy support for clinical evaluation, study design, oversea clinical data analysis & submmision etc. to better evaluate clinical safety and effectiveness of product concept/prototype/final product prior to product launch. • Study design – Protocol writing, collaborates on the statistical analysis plan/data management plan, monitoring plan. • Study execution – Plans, implements, and manages clinical trials, and interprets results. Defines clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) in clinical operations. • Study execution – Manages the budget & recommending resources to support projects, effectively drives action plan deliverables to OTD. • Study execution – Sets up new clinical sites for responsible clinical trials, keeps good relationship with investigators, KOLs. • Study execution – Organizes and manages clinical investigator meetings. • Study reporting – Data analysis & presentation to internal and external stakeholders, contribution to clinical reports and peer-reviewed publications. • Be responsible for multiple product lines for project management and quality control for registrational clinical trial, give leadership for team members for clinical trial development. Give co-monitoring and trial quality control to ensure clinical trials meet NMPA

. • Keeps effective collaboration across functions (biostatistics, data management, regulatory, quality, R&D etc.) and external partners (investigators, subject matter experts, Contract Research Organizations) on product development process deliverables.Good interface with government agency, cultivate relationship with vendors, consultants, contractors, and professional associations, engage in NMPA consultation, be clear with NMPA regulation and IVD and CDx clinical trial requirements. • Drives sustainment & improvement of functional standard work. • Maximizes the Danaher Business System (DBS) and tools to develop and deliver high-quality Global Clinical Affairs (GCA) standard work processes.