Vice President Clinical Operations @ Ascentage Pharma
Sr. Clinical Research Scientist @ AstraZeneca Pharmaceuticals
As a clinical professional for over 16 years, I have managed clinical trials ranging from Phase I-IV. My career has given me the opportunity to work in a myriad of therapeutic areas including CV, oncology, metabolics, infectious disease and respiratory/inflammation. I have worked for small biotechnology start-ups, medical devices companies, a world-renowned academic institution and an industry
As a clinical professional for over 16 years, I have managed clinical trials ranging from Phase I-IV. My career has given me the opportunity to work in a myriad of therapeutic areas including CV, oncology, metabolics, infectious disease and respiratory/inflammation. I have worked for small biotechnology start-ups, medical devices companies, a world-renowned academic institution and an industry leading pharmaceutical company. I hold an MBA in HealthCare Management and a Bachelor’s degree in Biology. I have a proven track record of operational excellence including successfully leading global trials in Eastern and Western Europe, Canada, India, Japan and the United States. I believe the combination of my diverse skill set, wide range of clinical experience, management background and strong education will enable me to thrive in a senior clinical management position.
Specialties: Project Planning/Scheduling, Project/Change Management, GCP/ICH guidelines, Outstanding Communication skills, Business Development, Budget Planning/Administration, Team Building and Leadership, Process Development, Contract Negotiations, Cost Reduction & Avoidance, Mentoring, Problem Solving, Quality Assurance, Multi-Site & Global Projects
Associate Director, Clinical Operations @ Directs development of current program level training materials, program slide updates for
management, and program level template. Provide/support program level presentations & training
Lead cross functional and multi-organizational projects teams to ensure all processes are
streamlined and result focused
Advanced understanding of drug development principles, clinical trial implementation and
management. Strong knowledge of global regulatory requirements and compliance, biostatistics,
data management, technoolgies role in recruitment and medical writing. From February 2011 to Present (4 years 11 months) Sr. Clinical Operations Project Manager @ From June 2007 to February 2011 (3 years 9 months) Clinical Operations Project Manager @ Manage the clinical development and financial oversight of new drug
compounds from Phase I to product launch.
Prepare RFP templates and financial analysis of CRO proposal
costs and negotiation.
Assist in protocol development and writing.
Plans, implements and manages, in collaboration with CRO partners, Phase I-III clinical trials, as necessary.
Works with multidisciplinary project team and CRO partners to
ensure that the clinical trials are completed on-time and within budget. From June 2005 to June 2007 (2 years 1 month) Sr. Clinical Research Scientist @ Manage multiple clinical trials to ensure project success.
Plan and implement medical device trial with critical marketing implications.
Lead US based e-clinical StudyWebs initiative.
Responsible for training, supporting and mentoring all US clinical study teams in the use and benefits of WBDC, SDE and StudyWebs.
Collaborate with global colleagues to develop and present robust interactive training platforms for on-line learning.
Manage internal and external resources including CRA’s and CRS’s.
Conduct on-going training, career development and formal mentoring for CRA’s and CRS’s. From June 2002 to June 2005 (3 years 1 month) Assoc. Dir Clinical Monitoring @ From July 2001 to June 2002 (1 year) Sr. Clinical Research Coordinator II @ Developed, implemented and monitored a five year longitudinal study on the impact of cocaine use and/or HIV infection on subclinical
atherosclerosis in substance abusers
Solely responsible for a budget in excess of $500,000.00
Created study SOP’s in accordance with University CHR and IRB
Drafted preclinical and clinical protocols and amendments, adverse event reports and serious adverse event reports
Adhered to policy from the IRB, CHR, CDC and FDA and other
regulatory agencies to ensure patient safety and GCP From April 2000 to June 2001 (1 year 3 months) Supervisor of Survey Research and Clinical Recruitment @ From October 1997 to April 2000 (2 years 7 months)
MBA, Health Care Management @ Regis University From 2002 to 2004 B.S., Biology @ Morgan State University From 1993 to 2001 William Garrett is skilled in: Clinical Development, Oncology, GCP, Clinical Trials, CRO, Quality Assurance, Business Development, Biotechnology, Team Leadership, Cross-functional Team Leadership, IND, Drug Development, Infectious Diseases, Clinical Research, Public Speaking
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