karen chang

assistant manager

About

- Dedicated, self-managing clinical trial and healthcare professional with a strong project management background - Effective problem solver able to integrate and synthesize information and opinions from many different sources into satisfactory solutions for all involved - Strong communicator and effective listener that builds teams and fosters cooperation KEY STRENGTHS - Over 10 years experience in clinical research - Trained in GCP, ICH, CFR, PHIPA, Tri-council Policy and Health Canada regulations governing clinical trials - Extensive computer skills including MS Office, Project, Visio, and Adobe Creative Suite - Training, Development, and Mentoring - Excellent verbal and written communication skills

Country

canada

City

toronto

Industry

biotechnology

Skill

stem cells, cell, clinical trials, biotechnology, research, molecular biology, biomedical engineering, cell culture, lifesciences, manufacturing, analysis, data analysis, clinical research, cell therapy, tissue culture, project management, engineering, cell biology

Experience

project manager

stem cell network

2003-1 - 2005-1 · 2 yrs 1 mo

* Managed two Network funded projects, Stem Cell Plasticity, and Culture Conditions for Human Embryonic Stem Cells, each involving over 10 investigators across Canada * Fostered cross-Canada collaboration through active communication * Facilitated group meetings and teleconferences * Projects met all milestones

project manager

university health network

2005-7 - 2013-9 · 8 yrs 3 mos

* Successfully carried out 5 clinical trials through varying stages from launch, to monitoring, and close-out, with 3 more in pipeline * Contributed to Clinical Trial Applications (CTAs) by writing Standard Operation Procedures (SOPs), Investigators Brochures, and Clinical Research Forms (CRFs) * Prepared Research Ethics Board (REB) and Ontario Cancer Research Ethics Board (OCREB) submissions and renewals for all human-subject work * Team member of consortium awarded $20 million from the Canadian Foundation for Innovation for the construction of GMP facilities for the production of cell therapy products for use in clinical trials * Trained technicians in GCP and GMP for clinical trial-related work * Developed and delivered a Canadian Stem Cell Network sponsored training workshop entitled “Introduction to Developing a Clinical Trial Application (CTA) for Cell-Based Therapies” * Managed the manufacture of clinical-grade cell therapy products for use in clinical trials, developed GMP-level cell production processes, as well as assays measuring cell effectiveness.