REPORTS TO: Associate Director China Clinical Affairs CCIA

JOB DESCRIPTION:

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. Manage the budget for projects and recommending resources to support projects, effectively drives action plan deliverables to OTDBe responsible for multiple product lines for project management and registration purpose clinical trial quality control, give leadership for team members for clinical trial development. Give 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, engage 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 workOversea data submissionLead 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

WORKING RELATIONSHIPS AND CONTACTS:

External contacts include hospitals, CROs, NMPA.Internal contacts include headquarter, program team, regulatory team, quality team, marketing team, sales and all other relevant functions, to make Programs done.

TRAVEL REQUIREMENTS:

This position may require business traveling in an ordinary situation.

WORK ENVIRONMENT AND PHYSICAL DEMANDS: 

This position functions in a general office environment. 

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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.