Medical Management
Resume:
Qiao (Phoebe) Zhang
Tel: 1-403-***-****, Email: *******@***.***
Work Experience
l Clinical Affairs Specialist May 2013 - present
Siemens Ltd. China, Beijing, China
Negotiate and acquire product licenses for critical Siemens products in mainland China.
Manage and lead monitoring team, report on the conduct of clinical trials to verify compliance with protocol and
regulatory requirements, plan monitoring visits and activities, and report to relative stakeholders.
Design and create clinical trial documentation packages including protocols and required registration documents.
Present technical and clinical affairs documentation to local authorities, expert panels and medical institutions;
act as a liaison and build relationships between Siemens, customers, medical institutions, and authorities.
Responsible for post market surveillance of critical products in market.
Fast and efficient handling of clinical trials of all product lines to be registered in China; set up SOPs of clinical
trials for all imported products; prepare, manage and coordinate clinical trial plans and activities; take care of
product-specific clinical deadlines to meet registration timetable.
An integral member of the Quality Assurance Board, and responsible for organizing and hosting regular meetings;
member of Siemens Healthcare worldwide Clinical Team, and responsible for Chinese clinical evaluation and
clinical trial regulatory affairs; member of COCIR Clinical Evaluation & Trials Task Force group.
Support regulatory affairs tasks.
l Research Associate Nov. 2010 - Nov. 2012
Alberta Health Services, Edmonton, Alberta, Canada
Member of the Edmonton Scoliosis Research Team, and providing technical and clinical support to the paediatric
scoliosis program at the University of Alberta Hospital and Glenrose Rehabilitation Hospital.
Researching, analyzing, and collecting scoliosis data at regular clinics to provide innovative diagnosis techniques
using surface topography (laser), Ultrasonix and Tomoview (ultrasound) in favor of radiation based methods.
Present at regular meetings and conferences, literature reviews for grant application, and document update.
Working with doctors, patients, and engineers on a daily basis in order to achieve research goals, and managing
and supervising undergraduate and junior students.
Relevant Skills
In depth knowledge and understanding of clinical affairs and regulatory affairs of medical devices, clinical
trial experience and knowledge of regulations, GCP principle and ISO standards.
A broad based knowledge of the products within the in-vitro diagnostics industry.
Strong communication, problem solving and group skills including community collaboration, time management
and supervision of projects; experience working in a high pressure environment under time constraints.
Management experience, excellent coordination skills in planning, organizing and managing activities.
Presentation and public speaking experience for project progress, protocols and research findings.
Clinical and research experience in the healthcare system that involves organizing and maintaining projects,
working with team members and patients, and analyzing research data.
Proficient in Microsoft Office Suite, C, MatLab, SPSS, ImageJ, Full-Torso Surface Topography System, Polygon
Editing Tool, Olympus TomoScan Focus Phased Array Ultrasound System, TomoView, Ultrasonix, and LaTeX.
Fluent in both English and Mandarin Chinese.
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Education
l M.Sc. Biomedical Engineering Aug. 2010
University of Saskatchewan, Canada
Advisor: Dr. Seok-Bum Ko & Dr. Yang Shi - Cumulative average of 88%
Thesis Topic: “Cuff-free Blood Pressure Estimation Using Signal Processing Techniques”
Specializing in the areas of control systems, digital signal processing, biological data acquisition
Courses: Mathematical Methods in Engineering, Digital Control Systems, Advanced Topics in Control System
Design, Advanced Computer Control Systems
l B.Sc. Biomedical Engineering Jun. 2008
Beijing Institute of Technology (BIT), China
Cumulative average of 85% - Graduated with Honors
Relevant Courses: Automatic Control Theory, Digital Signal Processing, Random Signal Analysis, Biomedical
Signal Detection & Process, Engineering Mechanics, Computer Programming-C language, Probability &
Mathematical Statistics, Principle of Microcomputer & Interface Technology, Digital Circuits & Systems
Publications
C1. Q. Zhang, Y. Shi, D. Teng, A. Dinh, S. B. Ko, L. Chen, J. Basran, V. D. Bello-Haas and Y. Choi (2009). Pulse
Transit Time-based Blood Pressure Estimation Using Hilbert-Huang Transform. In 31st Annual International
Conference of the IEEE Engineering in Medicine and Biology Society.
C2. E. C. Parent, P. Q. Zhang, D. Hill, M. Moreau, D. Hedden and E. Lou (2012). Sensitivity-to-change of full torso
surface topography measurements in adolescents with idiopathic scoliosis and a main thoracic curve. In 9th
Biannual International Research Society of Spinal Deformities Scientific Meeting.
C3. W. Chen, E. H. M. Lou P. Q. Zhang, L. H. Le, D. Hill (2013). Reliability of assessing the coronal curvature of
children with scoliosis by using ultrasound images. In Journal of Children’s Orthopaedics.
Certificates
Project Management training Mar. 2015
Siemens Learning Campus
Implementation and Management training of Clinical Trials for Medical Device Nov.
2013
China Food and Drug Administration Institute of Executive Development
ISO 13485 Medical Device-Quality Management System Aug. 2013
SGS-CSTC Standards Technical Services Co. Ltd.
ISO 9001 Quality Management System Internal Auditors Jan. 2007
China Certification Center Inc.
Honors/Awards
University of Saskatchewan-BIT Scholarship Sep. 2008 -Sep. 2009
Encouragement Award at the Future Innovators University Design Competition hosted by American Analog
Devices Inc. (ADI) 2007
Encouragement Award for Thesis in the top 10% of competitors, BIT 2007
First Class Excellent Student Scholarship for achievement in top 10% of Biomedical Engineering, BIT 2006
References
Available upon request
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