Danaher Corporation Clinical Affairs Supervisor in Beijing, China
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The primary responsibilities for the Clinical Affairs Supervisor include:
Plan, implement and manage clinical trials and influences study design and interprets results. Define clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) for use in clinical trials operations.
Develop clinical validation strategies, clinical study plans, and clinical protocols to evaluate safety and clinical efficacy aspects of products concept/prototype prior to product release, effectively drives action plan deliverables to OTD
Provide co-monitoring and trial quality control for CRA to ensure that clinical trials meet requirement of NMPA;
Organize and manage clinical trial investigator meetings for responsible projects;
Keep effective communication cross functionally and geographically.
Set up new clinical sites for responsible clinical trials, keep good relationship with investigators, KOLs;
Good interface with government agency, cultivate relationship with vendors, consultants, contractors and professional associations, e ngage in NMPA consultation, be clear with NMPA regulation and IVD clinical trial requirement.
Drive clinical evidence strategy for multiple projects (including leveraging oversea clinical data for local regulatory submission)
Drives sustainment & improvement of functional standard work
Oversea data submission
Lead and Identify the appropriate DBS tools to solve complex issues, utilize DBS to drive process improvement (i.e. creating SW, leading Kaizen, leading DM, leading PSP), manage risks, and propose the appropriate countermeasures
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.