CRA, data manager,Clinical trial coordinator Resume

Desired Industry: Healthcare	SpiderID: 22768
Desired Job Location: Toronto, Ontario	Date Posted: 9/26/2008
Type of Position: Full-Time Permanent	Availability Date: ASAP
Desired Wage:
	U.S. Work Authorization:
Job Level: Experienced with over 2 years experience	Willing to Travel: Yes, 50-75%
Highest Degree Attained: Bachelors	Willing to Relocate: Yes

Objective:
I'd like to find a job in clinical research field, positino such as clinical research associate, data manager, clinical trial coordinator.

Experience:
Pfizer China R&D Center (Shanghai) (2006 每 Jun2008)
http://www.pfizer.com/

Data Manager

Responsible for ensuring the completeness, quality and integrity of the subject data stored within the clinical trial database; responsible for data cleaning aspects of the data management role within a clinical trial, according to Pfizer Development Operation Standards, Processes and Standard Operating Procedures (SOPs); work with the global study team to meet the study objectives in the release of databases; provide tutoring and on job training for the newly onboard data managers.
Involved in every aspect of data management, including Study Start-Up, Study Conduct and Database Lock; experienced on all kinds of studies: paper, RDC and I*net. Very familiar with MedDRA and WhoDrug, have great interest in coding related issues.
l Ensure that all programs, outputs and documentation are consistent with relevant regulatory requirements (e.g. ICH-GCP)
l Ensure clear and timely communication with study team members to enable improvements to be implemented during the study and also the proactive planning of workload to ensure study timelines are met.
l Regular liaison with manager to assess workload and priority activities and status of assigned tasks and projects.
l Work with China Center management to give input to project plans and implement resource strategies to achieve center goals.
l Main studies involved:

1. A PHASE 3B MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY COMPARATIVE TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AZITHROMYCIN SR (MICROSPHERES FORMULATION) VERSUS MOXIFLOXACIN FOR THE TREATMENT OF ACUTE EXACERBATION OF CHRONIC BRONCHITIS (AECB)
2. A PHASE 2, RANDOMIZED, PLACEBO AND ACTIVE-CONTROLLED, DOSE-RANGING STUDY OF PF-00489791 AND LOSARTAN IN SUBJECTS WITH STAGE 1 AND 2 ESSENTIAL HYPERTENSION USING AMBULATORY BLOOD PRESSURE MONITORING (ABPM)
3. A SIX-MONTH, OPEN-LABEL OUTPATIENT, PARALLEL GROUP TRIAL ASSESSING THE IMPACT OF INHALED INSULIN (EXUBERA?) ON GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE POORLY CONTROLLED ON TWO ORAL ANTI-DIABETIC AGENTS. Exubera as an Alternative to usual Care in patients failing Two oral Agents
(EXACTA)
4. AN 8-WEEK, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF XALACOM TM WITH THE COMBINATION OF UNFIXED LATANOPROST AND TIMOLOL IN SUBJECTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION.

Bristol-Myers Squibb (China) Investment Co.,Ltd. (Shanghai)(2003-2006)
http://www.bms.com/

Clinical Trial Associate

l Organize investigators meeting, and coordinate between departments, be familiar with CRA＊s routine work, with experience of on-site monitoring; main project involved in: Entecavir study (Phase II and III)
l Get GCPㄛSOP training, participate in kick-off meeting and all other investigator meetings, follow up the whole trial process˙
l Familiar with drug developing & registration process and medical/pharmaceutical documents, familiar with IMPACT and other clinical trial management systems.
l Good adaptability, be able to take business trips frequently, willing to study and to deal with different people. Used to take overseas trips for training in Australia, Europe, Singapore, etc.
l Main studies involved:

1. A Phase II Double-Blind, Randomized, Placebo-Controlled Study in China of the Safety and Efficacy of Entecavir in Patients Who Have Failed Lamivudine Treatment
2. A Phase II Study in China of the Safety and Antiviral Activity of Entecavir (BMS-200475) in Adults with Chronic Hepatitis B Infection
3. A Phase III Study in China of the Safety and Antiviral Activity of Entecavir vs Lamivudine in Adults with Chronic Hepatitis B Infection

Shanghai pharmaceutical GroupㄗAPI Business Unitㄘ: (2001~2003)
(Former Shanghai Hualian Pharmaceutical Co, Ltd)
http://www.pharm-sh.com.cn/eng/

Translator, GMP file management, Procurement Specialist

Familiar with GMP and ISO900 Quality system. Act as interpreter for Canadian Specialist when the company imports equipment; help with DMF preparation and FDA registration work.
l Source and quote the ingredients according to the requirements of headquarter, achieve the purchasing goal.
l Evaluate performance of supplier and locate qualified suppliers with best price and terms as possible; on time delivery
l Collect relevant market data and prepare relevant market report. Keep close and regular contact with suppliers
l Monitor and react to significant market trends and supplier. Reply queries of the US customers on COA, MSDS, etc.
l Update the database of manufactures and products˙ Enhance work efficiency.

Be familiar with purchasing process, import-export business and raw material industry. Provide product training and technical support.

Education:
Bachelor of Science in International Pharmaceutical Trade, China Pharmaceutical University, 2001
http://www.cpu.edu.cn/English/

Skills:
l Over 7 years of experience in pharmaceutical industry: R&D, international business & cooperation and quality management.
l Experience in database (Oracle Clinical) and clinical trial management system (IMPACT).
l Familiar with SQL
l Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design.
l Familiar with Serious Adverse Event database (eg.ARISg).
l Experienced data manager, familiar with both paper and RDC/EDC study
l Capability to communicate effectively in English, both verbally and written.
l Professionally trained in ICH-GCP and Clinical Trial Process.
l Experience working on large international multi-center clinical trials
l Have excellent organizational and planning skills in order to meet deadlines and to handle many projects at once whilst showing prioritizing skills.
l Have an excellent attention to detail and a methodical approach to work.
l Excellent Analytical, Interpersonal & Communication Skills with Good Team player qualities. Won ※Pfizer Team Awards 2008§ (Apr 7,2008)
l Overseas experience: training and working experience in Belgium, Australia and Singapore
l IELTS score:7. Fluent Mandarinㄛknow Cantonese

Reference:
Available upon request

Candidate Contact Information:

Name: Judy zhu
Street:	Phone: 416 878 5222
City: Toronto	Fax: -
State: Ontario
Zip: M2M 2A5
Web Site: