Kenneth Wu is a high-level expert, that works in St. Jude Medical on the position of Senior Clinical Manager since 2011. Kenneth Wu has earned professional experience in more than 17 positions at different companies. Kenneth Wu went to the University of Phoenix and got education from 1996 to 1998. Kenneth has such professional qualifications as Linear Regression Modeling With Duke University, Inferential Statistics With Duke University, and Introduction To Probability and Data With Duke University. San Francisco, California is the area, where this expert was known to live. Kenneth's email address and number are accessed through this website on demand.
Name variants:
Ken Wu,
Kenny Wu
Last updated May 31, 2024
Contact Information
Last Update
Feb 1, 2016
Email
ke**@kenwullc.com, kw**@comcast.net
Location
San Francisco, CA
Company
St. Jude Medical
Workplace
Senior Clinical Manager
Work History
Senior Clinical Manager
Minnesota
Manager and leader of 16 clinical professionals, in two west coast offices, conducting IDE and post approval clinical studies in cardiac rhythm management devices.
Recruited and developed ...
Aug 2011 — Jun 2015
Senior Clinical Manager
Clinical lead of Class II IDE US trial
Managing clinical operations as shared service between two Maquet companies
Exceeding historical benchmarks; ie. cycle times from final protocol to ...
2010 — 2010
Senior Clinical Manager
Led clinical team on development of Class II IDE US trial.
Managed clinical operations as shared service between two Maquet companies
Exceeded historical benchmarks; ie. cycle times from ...
2010 — 2010
Clinical Operations Consultant
Emeryville, CA
Organized clinical operations for the start up company;
Collaborated with team to developed clinical quality plans for all clinical trials ie. developing new SOPs, work instruction, new qu...
2008 — 2008
Clinical Operations Consultant
Developed standard status reports on ~15 global clinical trials; enrollment status, barriers and bottlenecks to efficiency, standardized timelines and identified resource constraints
Bench...
Jul 2006 — Feb 2008
Clinical Operations Consultant
Achieved new benchmark in productivity at medical device company
2x faster to enroll first patient, with 4x workload of previous year!
Managed 7 oncology trials
circa $35M program budget...
from Jul 2006
Clinical Operations Consultant
Achieved great productivity improvement at device company; 2x faster to enroll first patient, with 4x workload of previous year!
Saved $200k (~20%) and 3 months (~30%) on US phase I clini...
from Jul 2006
Associate Director of Clinical Operations
Department head of clinical operations
staff of >
70 FTE and contractors, annual budget exceeding $70M.
Grew department from 32 (2004) to >
70 (2006)
recruited experts leaders to n...
Jan 2004 — Nov 2006
Clinical Research Manager
100 Boston Scientific Way, Marlborough, MA 01752
Managed clinical team to develop 5 clinical development plans for new treatment indications on approved products
radiation program with 700 patients, 70 sites, over 4 years for $9M,
combi...
2000 — 2003
Director of Clinical Affairs
Company relocated from Northern to Southern California following merger of Eclipse and Cardiogenesis.
Facilitated integration of Eclipse's and Cardiogenesis' clinical programs
Prepared PMA...
2000 — 2000
Clinical Manager
Led team of 12 in clinical
site monitoring, data collection, QA audits and PMA submission of Class III device
Coordinated successful preparation for site and sponsor audits
mock audits, ...
1999 — 2000
Clinical Manager
Led team of 12 in clinical; site monitoring, data collection, QA audits and PMA submission of Class III device
Coordinated successful preparation for site and sponsor audits; mock audits, ...
1999 — 2000
Education
1996 — 1998
1986 — 1987
1980 — 1983
Occupations
Executive
Manager
Counselor
Leader
Scientist
Biotechnology Professional
Chief Revenue Officer
Operations Manager
Advisor
Managers
Biologist
Biological Scientist
Chief Executive
Skills
Clinical Trials
Clinical Development
Biotechnology
FDA
CTMS
Medical Devices
Oncology
CRO
Pharmaceutical Industry
GCP
Clinical Research
Sop
Infectious Diseases
Clinical Operations
EDC
Data Management
Validation
Interventional Cardiology
Ctms
Fda
Cro
Therapeutic Areas
Gcp
Protocol
Regulatory Affairs
Ich Gcp
Clinical Monitoring
Immunology
Drug Development
Pharmacovigilance
Good Clinical Practice
Edc
Quality Assurance
Cardiology
Regulatory Submissions
Medical Writing
Diabetes
Lifesciences
Capa
Life Sciences
Management
Clinical Trial Management System
Clinical Data Management
21 Cfr Part 11
Clinical Study Design
Neurology
Inform
Cross Functional Team Leadership
Metrics
U.s. Food and Drug Administration
Cro Management
R&D
FAQs about Kenneth Wu
What's the main profession of Kenneth Wu?
Kenneth is a Senior Clinical Manager.
What are the main profession of Kenneth Wu?
These person's professions are Executive and Manager
Where is Kenneth Wu located?
Kenneth Wu is currently located in San Francisco, California.
Does the expert have the email address?
ke**@kenwullc.com and kw**@comcast.net is Kenneth Wu's email address.
How many companies did Kenneth Wu work at?
The professional worked at 17 jobs.
What education does Kenneth Wu have?
Kenneth studied at the University of Phoenix from 1996 to 1998.
Are there any professional certifications, that Kenneth Wu has?
The professional received the following certifications: Linear Regression Modeling With Duke University and Inferential Statistics With Duke University.
Are there any awards, that Kenneth Wu received?
This person received awards and these awards are: Six Sigma Green Belt Regulatory Affairs Certification.