Vanessa Estrada
Summary
Results-driven clinical trial manager with extensive experience at Kumquat Biosciences, leading Phase I oncology studies. Skilled in vendor management and execution of clinical trials, demonstrating exceptional organizational skills. Capable of identifying risks proactively, ensuring trials are completed on time, and fostering teamwork to achieve objectives ahead of schedule.
Overview
14
14
years of professional experience
Work History
Clinical Trial Manager
Kumquat Biosciences
San Diego
02.2025 - Current
- Study Lead for two Phase I Oncology studies.
- Responsible for oversight of active clinical sites and patients. Closely collaborating with investigators and study personnel to ensure successful trial execution and rapid dose escalation.
- Managing site start-up activities, including site feasibility, site selection, site contract review, site budget approval, ICF review, and site activation.
- Managing project timelines and resources, ensuring on-time and within-budget trial execution.
- Proactively identifying and mitigating risks and challenges throughout the course of the trial.
- Coordinating cross-functional teams to enhance communication and streamline collaboration across stakeholders.
- Responsible for CRO, IRT, and Central Lab vendor management.
Clinical Trial Manager
Kartos Therapeutics
Redwood City
12.2024 - 02.2025
- US regional lead for a global Phase II Immunology/Oncology study.
- Oversaw active US clinical sites and patients, collaborating closely with investigators and study personnel to facilitate successful trial execution.
- Managing site start-up activities for the US region, including site feasibility, site selection, site contract review, site budget approval, ICF review, and site activation.
- Led clinical operations data management, collaborating with data manager to clean data, identify trends, and resolve data issues.
- Reviewed monitoring reports and protocol deviations monthly to ensure compliance and address potential concerns.
- Identified and mitigated risks and challenges proactively throughout trial to support smooth execution.
Senior Clinical Research Associate
Kartos Therapeutics
Redwood City
01.2023 - 12.2024
- Study lead for a Phase II global Hematology/Oncology study and a Phase II Ophthalmology study.
- Successfully led a study from SMT kick-off meeting to database lock; study was delivered within budget and ahead of projected timelines.
- Ensured timely initiation, monitoring, and close out of clinical trial sites.
- Developed and executed study plans and study timelines.
- Performed co-monitoring visits and reviewed monitoring trip reports to ensure successful trial execution. Performed extensive data cleaning and review.
- Managed patient recruitment and retention strategies, meeting all trial objectives on schedule.
- Ensured continuous inspection-readiness of trial, supporting compliance and regulatory standards.
Clinical Trial Management Associate
Myovant Sciences, Inc.
Brisbane
08.2020 - 06.2022
- Contributed to Phase III global uterine fibroid and endometriosis studies by coordinating study activities and ensuring adherence to timelines.
- A key member of the Inspection Readiness Team. Participated in two FDA inspections and multiple mock inspections.
- Experience with trial management from start-up to close-out, which includes; RFP review, vendor selection, site selection, study maintenance, database lock activities and study archival activities. Working knowledge of ICH/GCP guidelines, international regulatory guidelines and the drug development process.
- Vendor manager for IRT, central lab, and imaging vendors. Experience with user acceptance testing, creation of vendor specific documents (i.e. study manuals, study charter), managing vendor payments, and monitoring of key performance indicators.
- Assisted with the creation of the TMF and responsible for our cross-functional quarterly TMF QC and reconciliation.
- Established and maintained comprehensive trackers for study lifecycle, including patient recruitment, clinical supply, site start-up, and vendor issues to enhance oversight and support informed decision-making.
- Managed sponsor oversight for sites, focusing on trip report reviews and trend identification.
Clinical Trial Assistant
Myovant Sciences, Inc.
Brisbane
08.2018 - 08.2020
- Supported Phase III global Women's Health studies.
- Participated in tracking and reporting study data for management reports.
- Assisted the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assisted with vendor management.
- Communicated directly with sites, Contract Research Organizations (CROs) and CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities.
Clinical Research Coordinator
UCSF Dept. of Psychiatry
San Francisco
11.2016 - 08.2018
- Responsible for recruitment and retention of study participants.
- Developed and maintained databases and data tracking tools.
- Assisted with manuscript writing and editing. Established and maintained partnerships with community based organizations.
- Responsible for IRB management, data processing, and supervision of data entry personnel.
Clinical Case Management Coordinator
Catholic Charities
San Francisco
03.2015 - 11.2016
- Coordinated clinical case managers at the HIV Women's Program, a world-renowned HIV clinic at Zuckerberg San Francisco General Hospital and UCSF.
- Worked closely with physicians and hospital staff in a clinical setting.
- Assisted patients in obtaining labs and other necessary exams.
- Developed and implemented care plans for women diagnosed with HIV/AIDS.
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, honesty, and integrity.
Research Assistant
UCSD, Anesthesiology Research Lab
San Diego
08.2012 - 08.2013
- Designed and developed a computer model that measures urinary function.
- Presented findings at the UCSD Undergraduate Research Conference 2013.
Education
B.S. - Cognitive Neuroscience
University of California
San Diego06-2013
Skills
- Adherence to standard operating procedures, ICH/GCP and, international regulatory guidelines
- IRT, EDC, Central Lab, Specialty Lab, and Imaging vendor management experience
- Strong clinical study execution, leadership, and project management skills
- Demonstrated ability to work independently with exceptional organization and attention to detail
- Mastery in MS Office
- Experience with Phase I, II, and III studies
- Contributed to two successful FDA inspections for treatments that obtained FDA approval
Therapeutic Areas
Oncology, Ophthalmology, Hematology, Women's Health
Legal Name
Vanessa Estrada-Gonzalez
Timeline
Clinical Trial Manager
Kumquat Biosciences
02.2025 - Current
Clinical Trial Manager
Kartos Therapeutics
12.2024 - 02.2025
Senior Clinical Research Associate
Kartos Therapeutics
01.2023 - 12.2024
Clinical Trial Management Associate
Myovant Sciences, Inc.
08.2020 - 06.2022
Clinical Trial Assistant
Myovant Sciences, Inc.
08.2018 - 08.2020
Clinical Research Coordinator
UCSF Dept. of Psychiatry
11.2016 - 08.2018
Clinical Case Management Coordinator
Catholic Charities
03.2015 - 11.2016
Research Assistant
UCSD, Anesthesiology Research Lab
08.2012 - 08.2013
B.S. - Cognitive Neuroscience
University of California