Project Manager Quality Assurance
Resume:
Deborah K. Mogaka
**** ******** ** # ****, ******** MN 55442
************@*******.***
OBJECTIVE
To be a part of the greater team that strives to make the world a healthier
and safer place to live in, by participating in health innovations, policy
making and implementation.
PROFESSIONAL EXPERIENCE
Medtronic Inc. Minneapolis MN Feb 2013 -
May 2013
Clinical Safety Specialist
. Adverse Event safety review and reporting
. Participate in product/therapy protocol development as well as
development of safety plan
. Ensure studies are in compliance with safety regulations
. Participate in the development of clinical safety plans
Golden living, Alixa Rx Minneapolis, MN May
2012 - Feb 2013
Pharmacy Implementation Specialist
. Implementation of pharmacy services and products
. Training of staff
. Report writing
Kemri Wellcome Trust Research Kilifi, Kenya
June 2009 - Aug 2013
Clinical Trials Facility Project Manager
. Providing oversight of all aspects of clinical trials from
inception to closeout
. Management of all operations of the clinical trials facility
. Managing and providing oversight in regulatory affairs and
Quality assurance
. Training staffs on GCP, Monitoring and other research related
competencies
. Supervision of clinical trials staff
. Budget and grant management
. Developing and maintaining standard documents needed for trials
e.g. SOPs
Life Care Centers of America Dallas, TX
Jan 2008- May 2009
Wound care and Charge Nurse
. Patient assessment and counseling
. Treatment and medication administration per doctor's orders
. Wound assessment and treatment
. IV insertion
LabCorp America Dallas, TX
April 2004 - Dec 2006
Laboratory Assistant
. Drawing blood from patients per orders
. Processing of lab specimens
. Data entry and taking inventory
Hennepin County Medical Center MPLS, Minnesota
March 2000 - Feb 2004
Nutrition Officer
. In charge of food safety, quality and regulatory activities
. Risk assessment of nutrition status
. Checking patient menus per nutritional needs
. Supervision of nutritional workers
Kenyatta National Hospital Nairobi, Kenya July 1996 -
Dec 1998
Nutrition Officer
. Mother, child assessment and nutritional counseling
. Surveillance and assessment of nutrition status of patients
. Develop therapeutic diets for patients per given guidelines
EDUCATION
Northcentral University In progress Phoenix Arizona
PhD BA-Project Management
Northeastern University Boston, Massachusetts
MSc September 2012
Regulatory affairs in drugs, biologics and medical devices
Columbus University Mississippi
Masters, Public Health Nov 2009
Dallas Nursing School Dallas, Texas
Licensed Vocational Nurse February 2008
University of Eastern Africa, Baraton Eldoret, Kenya
BSc Foods and Nutrition June 1996
OTHER ACHIEVEMENTS/ VOLUNTEER WORK
Pharmaceutical Training International - Certificate in pharmaceutical
regulatory affairs in EU and US
Kemri Wellcome Trust - Certificate in internal monitoring
- Certificate in GCP
Vienna School - Certificate in Project management in
clinical research
Pharma School USA - Certificate in clinical research
KIM - Certificate in Trainer of trainers
ADRA Somalia - Volunteered as Nutritional coordinator
Principle Investigator for the study: The Regulatory Pathway for a Vaccine
intended for developing countries: A case study of RTS,S AS01E
Monitored LLIN (Long lasting insecticide net) study for University of
Washington.
REFEREES
Mr. John Sitienei
Director of Nursing
Life Care centers of America
3800 Plano Pkwy, Plano TX, 75025
Tel: 972-***-****
Email: ****.********@****.***
Dr Robert Orina Nyarango
Head of Outpatient department
Gertrude's Garden Children's hospital
P.O Box 423**-*****, Nairobi, Kenya
Tel: 3763474-7, ext 239/240
Cell: +254*********
Email: *********@*******.***
Dr Sam Akech
Pediatrician
Kemri Wellcome Trust Research Programme
P.O. Box 230, Kilifi, Kenya
Tel: +254*********
Email: ******@*****.***
Dr. David Totoe
Principle Safety Specialist
Medtronic inc.
8200 Coral Sea pkwy, Mounds view,
MN, 55112
Tel: 203-***-****
Email: *****.*****@*********.***, ******@*****.***
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