Type Of Business:
Management company
Marketing Area:
International
Expertise:
Oncology; Cardiology; Neurology phase I-III
Major Product/SVS:
Clinical study operations management for pharmaceuticals
Hobbies/Sports:
Hand crafted silver and gem jewelry, and metalwork; CLG Jewelry Designs (www.clgdesigns.etsy.com); Running; Hiking; Wilderness camping; Cycling
Education Degrees:
MBA, Concentration in Health Care IT, University of California, Irvine (2005); Bachelor of Science in Nursing, Concentration in Biochemistry, University of Nevada, Reno (1997); CA Board Certified Registered Nurse (1997); Pre-Clinical Mammory Cancer Study Internship, University of Nevada Biomedical Research Department, University of Nevada School of Medicine (1996)
Affiliations Awards:
Society for Clinical Research Professionals; Society of Clinical Trials; Project Management Institute; BioPharmaPM Network; Association for Clinical Research Professionals
Industry:
Pharmaceutical Research & Development
Date of Distinction:
12/29/2011
Charity:
Monthly Donor, UNICEF; Doctors Without Borders; The American Red Cross; Miles for Smiles; Feed the Children; Breast Cancer Research
Number Of Years In Profession:
12
Number Of Years In Current Position:
6
What Does He/She Attribute Success To:
She attributes her success to drive and interest in drug development.
Why did you become involved in your profession or industry?:
She became involved in her profession through her interest in project management, following her initial career as a registered nurse.
Extended Bio Profile:
Ms. Green's mother, Joan Lockman, was her mentor.
Position Responsibilities and Duties:
Leading small, less complex phase I clinical trials to large multi-country phase III while working within the host country regulatory and ethical agency guidelines; Delivering oversight of operational aspects of one or more clinical research studies from protocol feasibility through database release in an effort to progress a new drug to market; Ensuring patient safety and providing high-quality, timely and cost-effective clinical data per protocol; Coordinating the activities and deliverables of all study team members and business stakeholders via telecommunication and face-to-face efforts as needed; Reporting regularly and/or presenting progress metrics to high-level stakeholders to ensure successful alignment with project plan and budgeting; Developing team charters; Updating protocol amendments and language; Creating study documents and reference training tools; Monitoring trainings as needed; Developing budgets and vendor oversight plans, contracts and other related items; Contributing to effective study reporting and close-out beyond database release; Completing New Drug Application (NDA) submission activities; Conducting FDA/EC audit/inspections including the development and implementation of corrective and preventative actions (CAPAs)
Education Certifications:
Pursuing Certified Clinical Research Professional Credential; Intermediate and Advanced Clinical Project Management (2011); Specialized Certificate in Clinical Research Administration (2001); Critical Care Nursing (1999); Good Clinical Practice Certification
Awards/Honors:
Spirit of Nursing Award, Army Nurse Corps and NSNA (1997)
Where Will You Be In 5 Years:
In five years, Ms. Green aims to move to the next level of clinical project management.