Experience

Terns Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr Clinical Trial Manager

  • Aug 2021 - Present

  Foster City, California, United States As a Senior Clinical Trial Manager at Terns Pharmaceuticals, I am the study lead for TERN201-1007, a Phase 1b multi-center, randomized, double-blind, dose-ranging, adaptive, proof of concept study in patients with presumed non-cirrhotic non-alcoholic steatohepatitis (NASH). My day-to-day responsibilities include oversight of 6 CRO / Imaging / Lab vendors, study core team management, and executive leadership reporting. At the end of 2021, I successfully led the on time completion of two interim… Show more As a Senior Clinical Trial Manager at Terns Pharmaceuticals, I am the study lead for TERN201-1007, a Phase 1b multi-center, randomized, double-blind, dose-ranging, adaptive, proof of concept study in patients with presumed non-cirrhotic non-alcoholic steatohepatitis (NASH). My day-to-day responsibilities include oversight of 6 CRO / Imaging / Lab vendors, study core team management, and executive leadership reporting. At the end of 2021, I successfully led the on time completion of two interim analyses in under 5 months followed by initiation of the study's second higher dose cohort in February 2022. In October 2022, I led the team to complete final study database lock and closeout followed by final statistical analyses. Show less



Exact Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Trial Manager II

  • Dec 2019 - Jul 2021

  Redwood City, California, United States As a Clinical Trial Manager at Exact Sciences (formerly Genomic Health), my main responsibilities involved coordinating operations for clinical trials on the Oncotype SEQ Liquid Select, Oncotype DX IBC, Oncotype DX GPS, and Oncotype MAP Pan-Cancer Tissue assays in Lung, Breast, Bladder, and Prostate cancer. From study initiation to completion, my tasks included writing and designing protocols, developing budgets and timelines, reviewing contracts, on-site hospital initiation / monitoring /… Show more As a Clinical Trial Manager at Exact Sciences (formerly Genomic Health), my main responsibilities involved coordinating operations for clinical trials on the Oncotype SEQ Liquid Select, Oncotype DX IBC, Oncotype DX GPS, and Oncotype MAP Pan-Cancer Tissue assays in Lung, Breast, Bladder, and Prostate cancer. From study initiation to completion, my tasks included writing and designing protocols, developing budgets and timelines, reviewing contracts, on-site hospital initiation / monitoring / closeout visits, IRB submissions and correspondence, internal cross-functional team oversight, executive summary reporting, and more. In the summer of 2020, I also successfully led and completed the integration of the Clinical Affairs group within Exact Sciences' Precision Oncology business unit with that of Paradigm Diagnostics (acquired by Exact in 2020). Throughout the integration process, I was responsible for reviewing and harmonizing historical clinical trials, GCP compliance training, the SOP framework, and future sample / evidence generation needs. Finally, I have provided operations input and support in establishing new pipeline products for the Precision Oncology business unit including early development of sample acquisition, clinical validation, and clinical lab experience studies. These projects consist of regular communications with Exact Executive Leadership and key stakeholders as well as external collaborators to discuss strategic product roadmap 5-10 year planning. Show less



Genomic Health

• United States
• Biotechnology Research
• 100 - 200 Employee

• Clinical Trial Manager II

  • May 2018 - Dec 2019

  Redwood City, CA

• Clinical Research Associate

  • Feb 2017 - May 2018

  My CRA responsibilities revolved around the management and operation of clinical trials for the OncotypeSEQ Liquid Select products. On my projects, I was in charge of timeline and budget development and tracking, cross-functional team management, contract negotiations, >50 international site and vendor in-person qualifications and trainings, external vendor oversight, sample collection and tracking, invoice processing, and document maintenance. I also successfully managed and… Show more My CRA responsibilities revolved around the management and operation of clinical trials for the OncotypeSEQ Liquid Select products. On my projects, I was in charge of timeline and budget development and tracking, cross-functional team management, contract negotiations, >50 international site and vendor in-person qualifications and trainings, external vendor oversight, sample collection and tracking, invoice processing, and document maintenance. I also successfully managed and completed the Physician Experience Program for the targeted launch of the OncotypeSEQ Liquid Select product. Program responsibilities included supervising a team of Medical Science Liaisons, contract execution with physicians, sample kit distribution and tracking, inquiry triage, survey development, and report QC for the Molecular Tumor Board review. Lastly, I was involved in the development and training of department Standard Operating Procedures and Good Clinical Practice in preparation for FDA governance.

• Clinical Trial Assistant

  • Jan 2016 - Jan 2017

  Redwood City, CA As a CTA, my responsibilities revolved around assisting in the management and operation of clinical trials for the Genomic Health OncotypeDX for Prostate Cancer and OncotypeSEQ Liquid Select products. I was involved with or responsible for protocol development, IRB submissions, contract and budget negotiations, site start-up and management, sample collection kit distribution, sample tracking, invoice processing, enrollment and study timelines and projections, running weekly study team meetings,… Show more As a CTA, my responsibilities revolved around assisting in the management and operation of clinical trials for the Genomic Health OncotypeDX for Prostate Cancer and OncotypeSEQ Liquid Select products. I was involved with or responsible for protocol development, IRB submissions, contract and budget negotiations, site start-up and management, sample collection kit distribution, sample tracking, invoice processing, enrollment and study timelines and projections, running weekly study team meetings, and document filing. I have also attended an in-person site initiation visit and a site monitoring visit. I also managed the Physician Experience Program for the targeted launch of the OncotypeSEQ Liquid Select assay. Program responsibilities include supervising a team of Medical Science Liaisons, contract execution with physicians, sample kit distribution and tracking, sample shipment tracking, inquiry triage, survey development, and report QC for the Molecular Tumor Board review.

• Translational Sciences Operations Intern

  • Jun 2015 - Dec 2015

  Redwood City, CA My main project as the Translational Sciences Operations Intern was to design and implement a Microsoft SharePoint intranet site for the Chief Medical Officer and 3 additional departments. I also assisted in the resource and FTE forecasting of the Translational Sciences organization for the 2016 operating plan. I was the Translational Sciences representative in the company-wide Planview software upgrade involving development input, user acceptance testing, and post-update team re-training… Show more My main project as the Translational Sciences Operations Intern was to design and implement a Microsoft SharePoint intranet site for the Chief Medical Officer and 3 additional departments. I also assisted in the resource and FTE forecasting of the Translational Sciences organization for the 2016 operating plan. I was the Translational Sciences representative in the company-wide Planview software upgrade involving development input, user acceptance testing, and post-update team re-training. Finally, I built a new sample and invoice tracking system for the Liquid Biopsy program clinical trials implementing Microsoft Visual Basic to greatly improve efficiency.



Zoeticx Inc.

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Summer Intern

  • Jun 2014 - Aug 2014

  San Jose, CA As an intern at Zoeticx, Inc., my main tasks included: testing their Electronic Medical Record (EMR) facilitation application and working with software engineers to improve it, helping to design a pharmacokinetic comparison and analysis website for doctors, and developing a business presentation for the Allscripts EMR conference in Chicago.



Boston University

• United States
• Higher Education
• 700 & Above Employee

• Learning Assistant

  • Sep 2013 - Dec 2013

  Boston University, MA As a learning assistant for introductory biology I had the opportunity to teach students while also gaining valuable lab experience. I helped lecture class material, answered students' questions, aided in leading field labs, assisted students with assignments, and discussed with faculty about how to improve the course. Additionally, I expanded my knowledge of lab procedures and the importance of note taking.



CIBSR

• Research Assistant

  • Jun 2013 - Aug 2013

  Stanford University, CA I had a hand in my team’s project from bottom to top including applying for funding, administering assessments, and eventually collecting data. I ran practice fMRI scans with participants and observed trials at El Camino Hospital. I also assisted my team in migrating from a paper to electronic filing system to aid in data analysis for paper drafting and submission.



Etkin Lab

• Research Assistant

  • Jun 2012 - Aug 2012

  Stanford University, CA As a research assistant in the Etkin Lab I gained first-hand site experience conducting clinical research. I phone screened potential participants for inclusion/exclusion criteria and helped coordinate and conduct EEG, TMS, and fMRI procedures. I also implemented a cranial measurement project for the ECAT_TMS study and wrote a procedures manual for future RAs to follow. Lastly, I was responsible for study data entry into the REDCap database.