Jason Carlson, Mph

Jason Carlson, Mph Email and Phone Number

Advocate for Data Integrity, Quality, Compliance | Innovative Research & Development Professional @ Aqtual, Inc.
Jason Carlson, Mph's Location
San Jose, California, United States, United States
Jason Carlson, Mph's Contact Details
About Jason Carlson, Mph

Demonstrated success working in a variety of settings, including start-up, biotech, pharma, medical device, consulting, and contract research organizations.Strengths include continuous process improvement, software development steering from a business owner perspective, data analytics, data quality and integrity, regulatory inspection preparedness, technical project management, exhibiting a sense of shared urgency, leadership, team development, partnership (health systems, academia, providers of solutions and services), stakeholder management, standards development, influencing, procedural document development, training, and striving for efficiency, quality, and consistency. 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, including R Shiny, Medidata RAVE, Medrio, Castor, TrialMaster, Oracle Clinical, SAS, R, Python, Veeva Vault eTMF, and internally developed solutions. 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

Jason Carlson, Mph's Current Company Details
Aqtual, Inc.

Aqtual, Inc.

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Advocate for Data Integrity, Quality, Compliance | Innovative Research & Development Professional
Jason Carlson, Mph Work Experience Details
  • Aqtual, Inc.
    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 (health systems, technology vendors, R&D collaborators, laboratories) to achieve and sustain data integrity, data quality, privacy, security, and GxP systems compliance supporting the total lifecycle of products developed and marketed by Aqtual.
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  • Pandora Bio, Inc
    Research Partnerships And Data Protection Lead
    Pandora Bio, Inc Nov 2022 - Present
    Leading and contributing to research and development of precision products using AI/ML with the aim to provide early detection and personalized resources to help young adults manage their mental and behavioral health. Lead for university research studies and other partnerships/collaborations. Data visualization tool development. Data privacy protection.
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  • Carlson Clinical Research And Development Consulting
    Clinical Research & Development Consultant
    Carlson Clinical Research And Development Consulting Nov 2022 - Apr 2024
    Consulting services and solutions including:- data collection and management strategy and execution- electronic data capture system configuration- software evaluation, validation, implementation, and utilization- coding interactive R Shiny data visualization dashboards- biospecimen data management - analysis dataset development - data integrity risk assessment- regulatory inspection readiness- procedural document development (SOPs, work instructions, policies, manuals, templates)- study-specific data management documentation- hands-on clinical data management from study start-up to closeout- vendor qualification assessment- collaboration with health systems, academia, pharma/biotech partners- coordinating data transfer receipt, reconciliation, quality review, and secure storage- facilitate cross-functional data review and decision-making- authoring data-related components of clinical study protocols and consent forms- coordination of data transfer receipt and reconciliation of multiple data sources- oversight, governance, and partnership with CRO, laboratory, and technology vendors- development of clinical study site payment tools- ensuring readiness for database lock, analysis, regulatory submission- end to end data flow and workflow coordination and curation of data for AI/ML model development- coaching, mentoring, training in data integrity, data quality, and data-related compliance
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  • Grail, Inc.
    Senior Director, Clinical Data Management
    Grail, Inc. Mar 2018 - Oct 2022
    Menlo Park, Ca, Us
    Accountable for the capture, curation, and management of clinical data for clinical studies in the US and the UK. Led a team of 19 clinical data management team members, and worked alongside collaborative, innovative, and mission-driven colleagues toward the goals of ensuring data integrity, quality, compliance, and privacy protection, at the intersections of clinical development, bioinformatics, data science, software engineering, and partnerships (health systems, academia, pharma, technology & service providers). Contributed to the development and launch of the first Multi Cancer Early Detection (MCED) product, while developing products to aid in the diagnosis of cancer and to support patient care in the post-diagnostic setting. Led or contributed to initiatives and project working teams including electronic data capture system software development, real-world evidence generation, data integrity, procedural development, health system partnerships, and analytics. Ensure that clinical data records are complete, consistent, and accurate. Perform study startup activities such as study protocol review, clinical data management plan development, and clinical database set-up, while collaborating with software engineering and data engineering to integrate with external systems. Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries and resolution of data discrepancies. Coordinate data locking efforts and preparation for analysis. Ensure that data integrity is maintained throughout the data lifecycle.
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  • Grail, Inc.
    Director, Clinical Data Management
    Grail, Inc. Sep 2016 - Feb 2018
    Menlo Park, Ca, Us
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  • Gilead Sciences
    Director, Clinical Data Management
    Gilead Sciences Apr 2009 - Sep 2016
    Foster City, Ca, Us
    Global Head of Clinical Data Management and EDC Programming, with responsibility for therapeutic areas including Oncology, HIV, HCV, HBV, Cardiovascular / Metabolic, Respiratory, and Inflammation for ~ 4.5 years. Provided oversight and support for internal CDM staff and clinical data management activities for all therapeutic area trials during the start-up, conduct, closeout, and archiving phases to ensure completeness, correctness, and consistency of the trial data. Support the planning and implementation of Biometrics department initiatives geared toward harmonization of procedures across Gilead sites, reduction in the number of disparate systems in use, enforcement of standards, as well as continual metrics-driven process evaluation and refinement. Coordinate efforts to integrate new departments post acquisition. Recruit, train, and retain excellent CDM staff. Foster collaborative partnerships with external partners. Prepare accurate cost and CDM resource projections to Biometrics management based on knowledge of the requirements for each therapeutic area and phase of trial. Review and author SOPs, working practices, and reference documents. Direct the activities of the EDC Programming group, ensuring use of best practices and enabling systems integration.Focussed on CDM activities in the Hematology/Oncology therapeutic area and Phase 1 trials across all therapeutic areas, as well as Document Processing/Clinical Records Management for ~ 2 years.Director, Biometrics (Quality, Efficiency, Standards/Systems, & Training) for ~ 1 year, leading an infrastructure group supporting Biostatistics, Clinical Data Management, Statistical Programming, and Bioinformatics, while collaborating extensively with other systems and procedures-focused groups across Development Operations.
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  • Cv Therapeutics
    Director, Clinical Data Management
    Cv Therapeutics Jan 2004 - Apr 2009
    Palo Alto, Ca, Us
    Company acquired by Gilead Sciences in 2009.
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  • Clinimetrics
    Assoc. Dir Clinical Data Management
    Clinimetrics Oct 2000 - Jan 2004
    San Jose, Ca, Us
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  • Roche
    Clinical Data Manager
    Roche Sep 1996 - Oct 2000
    Switzerland 🇨🇭 , Ch
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  • University Of California, Davis
    Data Assistant, Research And Training Center On Neuromuscular Diseases, Dept Of Physical Medicine
    University Of California, Davis Jul 1995 - Aug 1996
    Davis, California, Us
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Jason Carlson, Mph Skills

Clinical Data Management Edc Clinical Trials Data Management Clinical Development Cdisc Gcp 21 Cfr Part 11 Sop Clinical Research Electronic Data Capture Cro Management Standard Operating Procedure Clinical Trial Management System Data Quality Team Leadership Crf Design Quality Management Drug Development Data Standards Ich Gcp Good Clinical Practice Sdtm Meddra Protocol Sop Development Department Budget Management Computer System Validation Cdisc Standards Emotional Intelligence Biomarkers Data Visualization Organizational Leadership Global Resource Management Offshore Outsourcing Cross Functional Relationship Building Clinical Data Global Regulatory Compliance Data Integrity Cro Ctms Medidata Oracle Clinical Statistical Programming Onenote Ecrf Department Budgeting Planning Budgeting And Forecasting

Jason Carlson, Mph Education Details

  • Imperial College London
    Imperial College London
    Global Mph Program
  • University Of California, Davis
    University Of California, Davis
    Molecular And Cellular Biology

Frequently Asked Questions about Jason Carlson, Mph

What company does Jason Carlson, Mph work for?

Jason Carlson, Mph works for Aqtual, Inc.

What is Jason Carlson, Mph's role at the current company?

Jason Carlson, Mph's current role is Advocate for Data Integrity, Quality, Compliance | Innovative Research & Development Professional.

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What schools did Jason Carlson, Mph attend?

Jason Carlson, Mph attended Imperial College London, University Of California, Davis.

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What skills is Jason Carlson, Mph known for?

Jason Carlson, Mph has skills like Clinical Data Management, Edc, Clinical Trials, Data Management, Clinical Development, Cdisc, Gcp, 21 Cfr Part 11, Sop, Clinical Research, Electronic Data Capture, Cro Management.

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