Alexandria George
Redwood City,CA
Summary
Organized and dependable clinical operations professional successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
8
8
years of professional experience
1
1
year of post-secondary education
Work History
Clinical Trial Manager
Gilead Sciences Inc.
Foster City, California
1 2021 - Current
- Managed end-to-end P4 virology-focused clinical trials, primarily HIV treatment and prevention and HCV, from protocol development to final data analysis and reporting
- Currently providing operational oversight for the implementation of a new Expanded Access Program for BLV working closely with Medical Affairs and Clinical Development counterparts
- Coordinated with cross-functional teams including regulatory affairs, data management, and clinical operations
- Maintain oversight and management of external vendors and Clinical Research Organizations (CROs)
- Prepared and submitted clinical trial protocols, informed consent forms, and other essential documents for IRB/EC approval
- Collaborated with scientific leads from Medical Affairs and Clinical Development functions on study design and execution for several late phase studies
- Developed and implemented risk mitigation strategies to address protocol deviations, recruitment challenges, or regulatory issues
- Led root-cause analyses for trial delays or adverse events, implementing corrective action plans when necessary
- Negotiated contracts with vendors, clinical research organizations (CROs), and external laboratories
- Managed trial budgets, ensuring cost-effective allocation of resources while maintaining trial quality
Senior Clinical Trial Management Associate
Gilead Sciences Inc.
01.2021 - Current
- Productively manage multiple Gilead-Sponsored HIV/HIV PrEP studies from study-start up through clinical study report delivery and closeout
- Actively participate in the vendor selection process including but not limited to bid-defense meetings, negotiations, contracting, budgeting, vendor selection and kick-off
- Coordinate, schedule and manage study meetings and conference calls with key stakeholders, investigators and cross-functional teams as needed
- Develop study timelines and ensure on-track delivery of key targets, milestones and payments
- Identify key study risks and mitigation strategies during start up and throughout study lifecycle
- Support protocol development, review, and finalization with cross-functional teams
- Managed a portfolio of over 30 Investigator-sponsored/Collaborative Virology studies for the late-phase group
Senior Clinical Research Coordinator- Stanford Center for Clinical Research, Department of Gastroenterology
Stanford University Medical Center
07.2019 - 01.2021
- Fulfill all Clinical Research Coordinator tasks in addition to collaborating with the director of GI Motility and Neuro-gastroenterology to facilitate and manage several sponsor and investigator-initiated clinical research trials within the department
- Supervise research assistants in trial start-up, data management and recruitment strategies
- Work closely with leadership to develop and deliver educational programs for coordinators and newly appointed researchers
Clinical Research Coordinator - Department of Pediatric Anesthesia
Stanford University Medical Center
07.2016 - 07.2019
- Serve as primary contact for multiple research participants, sponsors, and regulatory agencies from startup thorough closeout of study
- Determine eligibility and gather consent from study participants according to protocol
- Assist in developing recruitment strategies
- Fully executing IRB e-protocol submissions, continuing reviews and amendments for both investigator-initiated and sponsored trials
- Develop study budgets using the budget workbook
- Initiate contract development and execution
- Ensure documentation and patient data is fully executed and stored in accordance with institutional, ICH Guidelines and GCP guidelines
- Conduct data analysis for publication submissions
Education
Master of Science - Health Sciences
Touro University Worldwide
Los Alamitos, CA 12.2018 - 12.2019
Bachelor of Science - Health Sciences
DePaul University
Chicago, IL 05.2001 -
Skills
Results-Oriented
Stakeholder Communication
Feasibility analysis
Research SOPs understanding
Teamwork and Collaboration
Problem-solving abilities
Research design
Training and mentoring
Standard Operating Procedures
Time Management
Timeline
Senior Clinical Trial Management Associate
Gilead Sciences Inc.
01.2021 - Current
Senior Clinical Research Coordinator- Stanford Center for Clinical Research, Department of Gastroenterology
Stanford University Medical Center
07.2019 - 01.2021
Master of Science - Health Sciences
Touro University Worldwide
12.2018 - 12.2019
Clinical Research Coordinator - Department of Pediatric Anesthesia
Stanford University Medical Center
07.2016 - 07.2019
Bachelor of Science - Health Sciences
DePaul University
05.2001 -
Clinical Trial Manager
Gilead Sciences Inc.
1 2021 - Current
Similar Profiles
KARL JOHNSONKARL JOHNSON
General Manager – Eastern Europe, Central Asia (EECA) Global Patient Solutions (GPS) at GILEAD SCIENCES INC.General Manager – Eastern Europe, Central Asia (EECA) Global Patient Solutions (GPS) at GILEAD SCIENCES INC.
Craig SullivanCraig Sullivan
Associate Director, Leadership Communications at Gilead SciencesAssociate Director, Leadership Communications at Gilead Sciences
Shelly SmithShelly Smith
HR Leader at Gilead SciencesHR Leader at Gilead Sciences