Jason Carlson

About Jason Carlson

Demonstrated success working in a variety of settings, including start-up, biotech, pharma, medical device, consulting, and contract research organizations.Strengths include data science and management with quality and integrity, product development, technical project management, regulatory compliance, cybersecurity and data protection, continuous process improvement, software development, data analytics, exhibiting a sense of shared urgency, leadership, team development, partnership (health systems, academia, providers of solutions and services), standards development, influencing, procedural document development, training, and striving for efficiency.Therapeutic area experience includes oncology, antiviral (HIV, HCV), cardiovascular disease, rheumatoid arthritis, diabetes, respiratory, liver disease, and post-organ transplant immunosuppression. Significant involvement in commercial product development and launches, including: Galleri, Zydelig, Harvoni, Sovaldi, Complera, Stribild, Ranexa, Cellcept.Broad range of experience with the development, evaluation, selection, implementation and/or utilization of software in support of clinical development operations.Partnership with hospital network collaborators to acquire clinical study data from electronic health records, resulting in a significant reduction in the need for manual data entry.Recent conference attendance and participation includes-Society for Clinical Data Management Annual Conference, Oct 2023-Application of Artificial Intelligence and Machine Learning for Precision Medicine, FDA and M-CERSI, Feb 2023-Establishing a High Quality Real World Data Ecosystem, Duke Margolis Center for Health Policy with FDA and Industry Speakers, Jul 2020-Developing Real-World Data and Evidence to Support Regulatory Decision-Making, Duke Margolis Center for Health Policy with FDA Speakers, Oct 2019-FDA Regulatory Education for Industry, Medical Device Track, May 2019-Healthcare Information and Management Systems Society, Feb 2019-FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials, Oct 2018-American Society of Clinical Oncology, May 2017-Exponential Medicine Conference, Nov 2015

Experience

1. VP Data Integrity and Gxp Systems

   Aqtual, Inc

   Apr 2024 — Present · Hayward, CA, US

   Accountable for leading and working alongside multidisciplinary team members within and external to the organization (clinical study sites, research partners, technology vendors) to achieve and sustain data quality and systems compliance, supporting the total lifecycle of products developed and marketed by Aqtual. Responsibilities and contributions include Clinical Data Science, Data Analysis, Data Visualization/Analytics, Quality, Data Integrity, Compliance, Regulatory, Cybersecurity, Data Protection, Publications, and Product Development.

Education

• Imperial College London

  Master of Public Health - MPH, Global MPH Program

  2020 — 2022

• University of California, Davis

  Genetics, Molecular and Cellular Biology

Skills

• Cdisc
• Sop
• 21 Cfr Part 11
• Clinical Trials
• Statistical Programming
• U.s. Title 21 Cfr Part 11 Regulation
• Drug Development
• Cdisc Standards
• Gcp
• Sop Development
• Computer System Validation
• Clinical Development
• Medidata
• CRO Management
• Ich-Gcp
• Offshore Outsourcing
• Quality Management
• Clinical Data Management
• Planning Budgeting & Forecasting
• Oracle Clinical
• Clinical Data
• Emotional Intelligence
• Good Clinical Practice (Gcp)
• Department Budget Management
• Data Visualization
• Cross Functional Relationship Building
• Data Quality
• Crf Design
• Data Management
• Global Resource Management
• Clinical Research
• CRO
• Clinical Trial Management System (Ctms)
• Biomarkers
• Team Leadership
• Standard Operating Procedure (Sop)
• Meddra
• Data Standards
• Edc
• Ctms