Ferdinand Javier
Senior Manager, Data Manager at IDEAYA Biosciences- Claim this Profile
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Bio
Credentials
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CodecademyJun, 2017- Oct, 2024
Experience
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IDEAYA Biosciences
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United States
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Biotechnology Research
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1 - 100 Employee
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Senior Manager, Data Manager
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Oct 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 Show less
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Corcept Therapeutics
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United States
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Biotechnology Research
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200 - 300 Employee
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Senior Manager, Data Manager
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May 2021 - Jul 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. Show less
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Genentech
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United States
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Biotechnology Research
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700 & Above Employee
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Study Data Manager
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Jul 2018 - May 2021
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. Show less
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Roche Molecular Systems
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Senior Clinical Data Manager
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Jul 2017 - Jul 2018
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. Show less
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Gilead Sciences
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United States
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Biotechnology Research
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700 & Above Employee
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CDA II
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Mar 2013 - Jul 2017
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 Show less
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PAREXEL
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Research Associate
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Sep 2010 - Jul 2012
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 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
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University of California Riverside
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United States
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Higher Education
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700 & Above Employee
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Research Assistant
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Feb 2009 - Apr 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. Show less
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Education
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2008 - 2010
University of Californa Riverside
Bachelor of Arts, Major: Psychology Minor: Neuroscience -
Gilroy High School
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Gilroy High School
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Gilroy High School
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Santa Monica College
N/A
Community
