Jason Carlson, Mph Email & Phone Number

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.

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.

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

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.

Menlo Park, Ca, Us

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.

Palo Alto, Ca, Us

Company acquired by Gilead Sciences in 2009.

San Jose, Ca, Us

Switzerland 🇨🇭 , Ch

Davis, California, Us

Master Of Public Health - Mph, Global Mph Program

Genetics, Molecular And Cellular Biology