# Ferdinand Javier > Principal Clinical Data Programmer @ IDEAYA Biosciences | Clinical Data Automation, Reconciliation & Analytics Location: San Francisco, California, United States Profile: https://flows.cv/ferdinandjavier I am a Principal Clinical Data Programmer at IDEAYA Biosciences with deep experience designing and scaling clinical data review, reconciliation, and analytics frameworks across oncology trials. My work focuses on building standardized and study-specific reporting systems that support real-time data oversight, cross-vendor reconciliation, and operational decision-making for Clinical Data Management, Clinical Science, Biostatistics, and Drug Safety teams. I specialize in leveraging R, and Python, API-based integrations to automate recurring workflows, improve data quality visibility, and reduce manual review effort across complex data ecosystems. I bring a strong background in clinical data management leadership and vendor oversight, and I enjoy partnering cross-functionally to translate data complexity into reliable, scalable solutions that move studies forward. ## Work Experience ### Principal Clinical Data Programmer @ IDEAYA Biosciences Jan 2024 – Present Design and deliver standardized and study-specific clinical data review, reconciliation, and metrics reporting frameworks across multiple oncology trials. Develop automated reconciliation and oversight pipelines using R, Python, SAS, and API integrations to support cross-vendor and eCRF data quality monitoring. Build recurring subject, visit, query, and missing data trackers used by Clinical Data Management and Study Teams for ongoing operational oversight. Partner cross-functionally with Clinical Data Management, Clinical Science, Biostatistics, Drug Safety, and Clinical Operations to define requirements and deliver actionable data review outputs. Provide technical leadership, training, and mentorship on scalable clinical programming and data review best practices. ### Senior Manager, Data Manager @ IDEAYA Biosciences Jan 2021 – Present Provide leadership for clinical data management (CDM) function; ensure DM deliverables are completed on time, within budget and in accordance with quality standards and study requirements Responsible for leading CDM activities for multiple trials Oversight of CRO and/or CDM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreements Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial Lead development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization outputs Lead preparation of CDM documents (e.g., Case Report Form [CRF] completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan) Lead/Oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IxRS, laboratory, Imaging) Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors Collaborate with Study Execution Team (SET), participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock Tables, Figures and Listings (TFLs) Report metrics/trends; identify barriers to timely and successful trial execution and propose solutions Lead clinical data review of data listings and summary tables with the SET Implement data review strategy via use of data integration or visualization platform Serve as a subject matter expert on CDM systems and processes Lead CDM standardization and development of Standard Operation Procedures (SOPs), work instructions and other infrastructure as needed ### Senior Manager, Data Manager @ Corcept Therapeutics Jan 2021 – Jan 2021 Day-to-day management of vendors involved in data production or manipulation, to ensure quality of deliverables and that set timelines are met. Develop and/or review study plans including but not limited to Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines. Review of study protocols to ensure that data collection and CRF design meet study objectives. Develop and/or review specifications for database build, edit checks, external system integration, or for other systems or processes related to data. Ensure data quality of clinical database through implementation of CDISC compliance. Review clinical data for completeness, accuracy and consistency in accordance with study plans. Input into the design of data flow across EDC and non-EDC data sources and across vendors. Develop and contribute to design of processes enabling near-real time data access for Corcept clinical trials. Review and critically assess data management metrics and suggests improvements. Manages and oversees SAE reconciliation between clinical and pharmacovigilance database. Manages and oversees external data reconciliation with the clinical database. Provide subject matter expertise to study team members during all phases of the project life cycle. Provides accurate and timely clinical data to internal and external consumers upon request. Manage development and periodic review of Data Management specific SOPs, WIs, and templates Provide subject matter expertise prior, during, and after internal and external audits and inspections. Maintain compliance with company and study-specific learning requirements. ### Study Data Manager @ Genentech Jan 2018 – Jan 2021 | South San Francisco, California Collaborate with peers within and across the organization Identify/design/execute meaningful data management solutions, ensure FAIR principles are adhered to. Expert for data collection and acquisition, advise teams and stakeholders Ensure best practices and propose innovative solutions e.g. the collection of new data types (e.g.emergent biomarkers), new technologies (e.g. sensors), and new data sources (e.g. RWD, EMR). Partner with/ provide oversight of data management deliverables to our Functional Service Providers(FSP) and vendors. Provide Quality Assurance on tasks as applicable, ensure a high quality of data compliance with applicable pharma industry regulations and standards. Proactively manage timelines and track decisions, ensure successful delivery of the study work packages carried out at FSPs. Oversee data quality, provide support in the form of business and technical expertise to FSPs. Oversee FSP in Sample management and eManifest process, ensuring timely, proactive resolution of queries. Provide high level review of data using graphical visualizations, statistical monitoring tools, and standard metrics Identify outliers or trends in data received, gaps and unexpected anomalies in the data. Biometrics rep for Study Leadership Team triad and associated meetings. Inform stakeholders of status of key deliverables and milestones. Proactively engage with stakeholders across the business and biometrics Understand needs and influence understanding of decisions made on biometrics function. Partner with relevant functions for external data vendor selection and management. Oversee development of data transfer agreements with vendors, ensure use of standards, appropriate data models and transfer intervals. Contribute to functional, cross functional, enterprise-wide or external initiatives that shape our future landscape. Contribute to clinical coding strategies; oversee the coding activities performed by FSP. ### Senior Clinical Data Manager @ Roche Molecular Systems Jan 2017 – Jan 2018 | Pleasanton, Ca Serve as technical and functional expert for the Clinical Project Teams. Primary Data Management representative. Develop CFRs in accordance with protocols and CDASH/CDISC standards. Provide guidance on data collection strategy, EDC system functionality, receipt and handling of electronic study data. Lead Data Manager on day to day activities on multiple projects on all phases of the studies (i.e. study start-up, data base lock, management of external vendors). Drive development of study documentation, database specifications, Data transfer agreements, and other study documents. Participation in study build activities, such as database validation and UAT. Manage ongoing review of data, query issuance, resolution, reporting metrics, handling electronic data transfers data auditing, and database locking. Develop and maintain a strong relationship with cross-functional team members. Work closely with SAS Programming to implement and configure electronic transfer process. Track and manage various data sources (i.e. eCRF data as well as external data i.e. lab data and/or test results from diagnostic instruments). Comprehensive knowledge of electronic data handling, storage, and archiving best practices. Responsible for managing large volumes of incoming electronic data transfers daily. Primary Data Management project manager for large/multiple projects. Mentors or directly supervise lower level team members . Independently propose project solutions to the Data Management teams and Management. ### CDA II @ Gilead Sciences Jan 2013 – Jan 2017 | Foster City, Ca Works collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and others Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for routine to basic clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of clinical data and data structure. Assists in the implementation of clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery. Assists in the preparation of CRF/eCRF data collection through the regulatory approval process. Assists field clinical staff in collecting data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves basic queries. Utilizes reports to track study progress and ensure timeliness and quality expectations are met. Basic knowledge of FDA regulations and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems. Able to effectively communicate and possess good problem solving as well as people/project leadership skills ### Research Associate @ PAREXEL Jan 2010 – Jan 2012 | Glendale, Ca Has detailed knowledge of the study protocols Enters study participants in tracking system, study logs Problem solves study participant issues as they arise Labels, inventories and sends plasma samples Assures quality and accuracy of source Prepares shipment of study samples Performs appropriate psychometric and efficacy testing 11/2010-7/2012 Assists staff physicians in assessment of concomitant medications, adverse events and lab results ### Research Assistant @ University of California Riverside Jan 2009 – Jan 2011 In this lab we do research on differentiation of cortical pathways of the cortex in mice. Currently under investigation is the development of cortical pathways following neonatal exposure to alcohol. I am responsible for recording daily alcohol intake and weight of the pregnant mother. We perform profusions and brain extractions after exposure. Then the brains are then injected with di-I and di-A tracing solution. After placing the brain in agar solution we use a vibratome to slice the brain into thin slices. We also study gene expression via In Situ Hybridization. ## Education ### Bachelor of Arts in Major: Psychology Minor: Neuroscience University of Californa Riverside ### Gilroy High School ### Gilroy High School ### Gilroy High School ### N/A Santa Monica College ## Contact & Social - LinkedIn: https://linkedin.com/in/ferdinand-javier --- Source: https://flows.cv/ferdinandjavier JSON Resume: https://flows.cv/ferdinandjavier/resume.json Last updated: 2026-04-12