Danaher Corporation Senior Clinical Research Associate-Beijing in Shanghai, China
Danaher Company Description
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or atwww.beckmancoulter.com.
Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
- To work as a project leader for preparing and conducting IVD or other medical advice clinical trials which are needed by registration in China. o Act as a main line with marketing related persons and LSS for the sample ordering o Communicate with CRO or other clinical agency for the trial preparation, such as protocol design o Work with CRO to conduct investigator selection, investigator meeting, and EC submission o Tracking to meet target including source data verification, timeline, enrolled sample number and budget, etc o Co-monitoring with CRA/CRO to ensure trial quality compliance with the requirement of ICH GCP, SOPs and local regulations o Managing document filing according to the requirement of SOP - Make the clinical trial planning and managing to get the clinical report and other required document in a target timeline - Good interface with government agency, manage relationship with vendors, consultants, contractors and professional associations - Adhere to policies and procedures
This position requires baccalaureate college degree of molecular biology, clinical laboratory medicine, molecular immunology or relevant clinical diagnostic fields and more than five years of clinical study experience for management expertise. This position also requires: - Be experienced in GCP quality system - Be familiar with regulatory requirement, Chinese & international regulation of medical devices and/or IVD - Resolves routine issues; identifies non-routine issues and may take actions to resolve - Continuously learns from experiences, particularly non-routine challenges - Overcomes potential stumbling blocks to achieve objectives - Understands complex technical and non-technical documentation - Effectively communicates with external contacts to ensure positive outcomes - Excellent team work and influential interpersonal communication skill - Good attitude, well habit of work, positive & take responsibility - Analysis & Judgment - Result oriented - Excellent English skills in speaking, reading and writing
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Beckman Coulter - Diagnostics
Job Function: Quality and Regulatory Affairs
Primary Location: Asia Pacific-China-China-Shanghai-Shanghai
Req ID: BEC012593