Ashley Salinas Email & Phone Number

Austin, Tx, Us

Austin, Tx, Us

Austin, Texas, United States

Lead Site Manager (SM) on J&J’s Phase 3, Open-Label, Multi-Center, Randomized Study. This study evaluates the efficacy and safety of TAR-200 in combination with Cetrelimab or TAR-200 alone versus Intravesical Bacillus Calmette-Guérin (BCG) in participants with BCG-naïve high-risk non-muscle invasive bladder cancer (NCT05714202)- Lead SM team overseeing 55 high-enrolling investigative sites across all US locations, including industry Key Opinion Leaders (KOLs), throughout the lifecycle of a global study to achieve competitive study timelines- Engage cross-functional team collaboration to ensure patient-centric care is delivered across the oncology solid tumor portfolio and recruitment and retention milestones are achieved (Study Responsible Physicians, Global Trial Leaders, MSL’s, Diversity, Equity, and Inclusion partners)- Manage data integrity and improve site level Key Performance Indicators such as time to data entry, query resolution, safety reporting via detail-oriented monitoring visits and purposeful site management- Develop study level workflows and guidance documents such Eligibility Worksheets, Vendor Access and Supply Reorder Guide, Recruitment and Retention Plans, and Process Mapping documents that increase SM productivity and create consistency- Mentor 15+ Site Managers on biweekly basis in group and 1:1 settings to actively seek feedback, oversee study progress, proactively identify risks, develop mitigation plans, and foster a safe and inclusive working environment- Live J&J Credo through 16 week assignment as Team Lead in a Global Pro Bono Consulting role as part of Talent for Healthy Communities initiative

Austin, Tx

A fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True HumanTM proprietary technology- Served as the Lead Clinical Research Coordinator during the procurement of a $750 million manufacturing and clinical trial services agreement between XBiotech and Janssen Pharmaceutical Company of Johnson & Johnson, now known as Johnson & Johnson Innovative Medicine- Recruited 50+ dermatology clinics for clinical trial participation, trained selected sites, managed protocol and data entry compliance, and monitored progress for two Phase II trials - Developed a wide range of company documentation, including standard operating procedures, protocols, electronic case report forms, monitoring guidelines, and reporting templates

Austin, Tx

- Provided direct patient care services in a fast paced environment while working closely with the registered nurses to anticipate patient and provider needs and improve the overall patient experience

New Braunfels, Tx

- Developed in depth understanding of the emergency department workflows, medical terminology, and managed documentation for the ER physician to increase overall productivity and decrease patient time to provider wait time