Marissa Ballesteros Email & Phone Number

New York, Ny, Us

New York, Ny, Us

San Francisco, Ca, Us

Morrisville, North Carolina, Us

-Member of leadership team responsible for the strategic direction and functional management of the clinical operations department-Provide insights in mobile/device technology and solutions to implement innovative virtual trials-Evaluate and solution new clinical trial opportunities from Sponsors and CROs-Seek new partnerships and opportunities to optimize clinical trial services-Collaborate with Product/Tech teams to continue building improvements to EDC platform-Develop and oversee task forces that generate deliverables to enhance public awareness of Science 37 capabilities

Denver, Colorado , Us

-Led and developed clinical validation protocols for biosensors in collaboration with Engineering teams-Led and developed digital intelligent outcomes and pharmacogenomics study protocols to feed into SaMD development-Collaborated with academic institutions and hospital systems and formed strategic relationships with pharmaceutical, IT, and health insurance companies-Provided clinical due diligence input of M&A candidates and payer/provider systems-Clinical lead for the development and maintenance of the pharmacogenomics reporting platform

San Diego, Ca, Us

-Led and developed clinical validation protocols for inhouse developed biometric sensor in collaboration with Engineering and Product teams-Led the development of study protocols with academic institutions and healthcare partners to feed data into SaMD development-Led data management and statistical analysis for validation protocols-Authored protocols and study reports-Supported key strategic partnerships with various third parties, including pharmaceutical/medical device, IT, and health insurance companies-Worked with sales team to drive the Qualcomm Life Capsule and 2Net products business-Provided clinical due diligence input of M&A candidates and clinical sites-Led the marketing working group of the Open Med Ready Consortium (Collaborators involved in the health and technology sectors to establish standards frameworks for remote healthcare)-Provided clinical input to Qualcomm Corporate 5G mission critical project

-Project Lead for "mHealth Screening to Prevent Strokes" (mStoPS - Collaboration with Aetna and Janssen)- NCT02506244 - Dr. Eric Topol-Project Lead for "Quell Opioid Reduction and Pain Relief in Patients with Cancer" - NCT02809846

Switzerland 🇨🇭 , Ch

-Lead for setting up Roche Shanghai early development Clinical Operations infrastructure and implementing overall department strategy-Leadership role in operational strategic planning, oversight and delivery of the early clinical development programmes and global clinical studies in the value chain -Key partner to Medical Leaders, Clinical Pharmacologists, Biomarker Leaders, Clinical Leaders and Project Team Leaders to ensure the effective implementation of the early clinical development strategy-Clinical operations contribution to Due Diligences-Lead Development Compliance Liaison for international Healthcare Provider/Sunshine Act Program-Leads a team of Study Leaders, Study Managers, and Study Associates.

Switzerland 🇨🇭 , Ch

-Coordinated and facilitated interaction between study team members in order to conduct early development studies to ensure the delivery of high quality clinical data.-Accountable for all clinical operations function within the study team, ie. planning, feasibility, logistics, coordination, budget preparation, site initiation, clinical conduct, monitoring, close-down.

-Developed Global Thought Leader Strategic Plans for the therapeutic area medical plan-Developed and facilitated thought leader engagement plan process and implemented the analysis of thought leader identification and influence mapping-Served as an active member on the Global and U.S. Medical Team as well as extended marketing teams to align and coordinate multi-department thought leader initiatives

Columbia, Maryland, Us

New York, New York, Us

Bs, Nursing

Mph, Epidemiology

Mba, Finance & Management