Vivian Pascual
Millbrae,CA
Summary
Accomplished clinical trial professional with 20+ years of clinical trial and project team management. Proven track record in overseeing global, multicenter clinical trials in the Sponsor and CRO settings with strong focus on oncology and early phase trials.
Overview
26
26
years of professional experience
Work History
Sr. Clinical Operations Consultant
Riboscience
01.2024 - Current
- Drive study start up activities including protocol and ICF development, creation of study plans and tools, vendor selection and management, EDC & IRT build, and other systems set up
- Lead data review and cleaning activities for a rescue study
- Partnered closely with translational medicine group to develop lab specification documents and site lab manual
- Contribute to SOP development and other Clinical Operations infrastructure building activities
Sr. Clinical Operations Consultant
Genentech
09.2017 - 09.2023
- Led study management teams focused on achieving study milestones within timeline and budget
- Led the clinical operations logistics team and created processes for personalized gene therapy trial
- Supported start up activities for a cell therapy trial including ICF development, designing logistical processes to support study drug manufacturing, and creation of study plans
- Participated in FDA inspection preparation for an early phase study
- Responsible for vendor selection and management including CRO, IRT, central and specialty labs, imaging vendor, etc
Sr. Clinical Trial Leader, Clinical Trial Manager II
Genentech
07.2007 - 06.2017
- Led and supported more than 10 Ph I and II cross-functional study management teams from study start up through close-out focused on achieving study milestones within timeline
- Achieved a cost savings of almost $1M dollar on CRO fees through close scrutiny of and negotiation of budget.
- Accountable for managing overall study budget and contributed to the clinical program budget
- Conducted protocol and site feasibility assessments
- Responsible for vendor selection and management focusing on budget and issue management
- Supported regulatory and EC/IB submissions including crafting responses to health authority and EC/IRB questions
- Reviewed data listings in support of interim analysis and final database lock
- Contributed to clinical trial protocol and ICF development
- Partnered with Procurement in development and negotiation of site budgets
- Collaborated with clinical supplies team to develop drug supply assumptions and manage drug supply throughout the study
- Mentored junior Clinical Trial Managers and Associates
- Participated in various departmental initiatives to create and/or improve processes within Clinical Operations
Lead Clinical Research Associate
PRA Health Sciences
07.2002 - 06.2007
Clinical Research Associate
Aventis Pharma
Manila
09.1998 - 06.2002
Education
BS -
Industrial Pharmacy
Skills
- Strategic Thinking
- Creative problem-solving
- Strong early-phase experience
- Cell & Gene Therapy
- Study Start-up
- Study & Site Management
- Study Budget Development & Management
- CRO / Vendor management
- Systems: EDC, eTMF, CTMS, IRT
- Mentor junior Clinical operations team members
Timeline
Sr. Clinical Operations Consultant
Riboscience
01.2024 - Current
Sr. Clinical Operations Consultant
Genentech
09.2017 - 09.2023
Sr. Clinical Trial Leader, Clinical Trial Manager II
Genentech
07.2007 - 06.2017
Lead Clinical Research Associate
PRA Health Sciences
07.2002 - 06.2007
Clinical Research Associate
Aventis Pharma
09.1998 - 06.2002
BS -
Industrial Pharmacy
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