MARJORIE ANDRADA JAVIER
Poway
Summary
Results-driven professional with extensive experience in both hands-on and leadership experience in the full cycle data management process. Adept at driving organizational success through effective team collaboration and dynamic problem-solving. Recognized for adaptability and keen focus on achieving objectives.
Overview
32
32
years of professional experience
Work History
Associate Director, Data Management
Astute Medical, Inc (bioMerieux)
01.2012 - 07.2024
- Led team of up to 4 personnel, supervising daily performance as well as training and improvement plans.
- Oversaw departmental budget planning processes, ensuring financial goals were met while maintaining optimal resource allocation.
- Established team priorities, maintained schedules and monitored performance.
- Assisted with the coordination of study and site closure.
Manager, Clinical Data Management
Astute Medical, Inc.
12.2009 - 01.2012
- Managed data management operations from study start-up to database lock and responsible for ensuring activities and processes performed were conducted according to GCPs and sponsor requirements.
- Designed CRFs and clinical database structures for data acquisition and data entry.
- Identified and resolved data flow process issues in collaboration with the project team.
- Defined data review guidelines, data handling conventions, edit checks, quality acceptance and auditing criteria.
- Created standard and ad hoc reports to efficiently identify outstanding queries and query types.
- Resolved queries, discrepancies and unanticipated data issues.
- Performed accurate database updates.
- Participated in the identification, review and evaluation of new data management technologies.
- Developed Data Management documentation, e.g., Data Management Plans, CRF completion guidelines and data entry training material.
- Liaised with third-party vendors such as database administrator, CROs and other vendors in a project-manager capacity.
- Responsible for managing full-time and contracted Data Managers.
Clinical Data Management Consultant
Storm Peak Associates, LLC
05.2009 - 08.2009
- Assisted Data Analyst in manual review of data listings, query generation and ad hoc reporting
- Carried out database cleanup activities in preparation for statistical analysis
- Mentored and provided guidance on standard data management procedures and guidelines
Clinical Data Manager
Boston Scientific (formerly CryoCor)
01.2001 - 01.2009
- Managed data collection, query generation and resolution.
- Audited site files and subject data for completeness and accuracy.
- Liaised with core lab to ensure quality and timeliness of data transfers.
- Prepared data and reports of SAEs for DSMB review.
- Supervised medication and adverse event coding activities.
- Produced data listings and reports used to present and defend clinical results at FDA Panel meeting resulting in a positive outcome.
- Negotiated EDC contract with existing database vendor that achieved a $60,000 savings.
- Coordinated activities required for database lock one month ahead of schedule with 100% closure of all data queries at study completion.
- Facilitated clinical database audit that resulted in a 99% error free rate.
- In the absence of a Clinical Manager, coordinated study closure activities and archiving of all clinical study files and ensured completion within deadlines and cost parameters.
Clinical Data Specialist III
Boston Scientific (formerly CryoCor)
01.2005 - 01.2007
- Data team lead, identified priorities and delegated tasks
- Headed the efforts in printing and distribution of clinical trial material
- Mentored junior level data associates
- Automated Case Report Form (CRF) tracking system by integrating it into database schema, which enabled all members of Clinical Affairs to track status of outstanding data
- Streamlined CRF design by applying observations from previous clinical trials
- Professionally represented the Data Management team during FDA audit for the first PMA submission which resulted in no corrective actions or issues for Data Management
- Collaborated with IT to successfully transfer the clinical database to a new server with no deviations and resulted in cost savings of $6000
- Recipient of the first 'No I in Team' award
Clinical Data Associate II
Boston Scientific (formerly CryoCor)
01.2004 - 01.2005
- Standardized the design, documentation, testing, and implementation of data collection methods
- Completed validation and implementation of database for first US Pivotal Clinical Trial with minimal supervision and training
- Developed reports of clinical trial results for senior management used to secure funding from venture capital firms
- Proactively identified resource needs and successfully hired and trained all data management personnel
Clinical Data Associate I
Boston Scientific (formerly CryoCor)
01.2002 - 01.2004
- Assisted in the development of clinical data management procedures and supported the review of clinical data in accordance with existing standards
- Took initiative to learn database capabilities without training instruction and expanded the functionality of the database for improved data storage and efficiency in reporting results
- Coordinated multiple investigator meetings
Temporary Data Entry
Boston Scientific (formerly CryoCor)
01.2001 - 01.2002
- Performed data entry for all US and European clinical trials
Marketing Communication Specialist
VistaInfo Property Disclosure
01.2000 - 01.2001
- Carried out all responsibilities related to collateral development and distribution
- Prepared marketing materials for display and presentation at Realtor tradeshows
- Coordinated direct mail campaign which included the distribution of over 30,000 flyers monthly to various realtor associations in southern California within given deadlines
- Developed database of Realtor contacts and associations used by the sales team to establish new accounts and relationships
Subject Recruitment Coordinator
Radiant Research
01.1997 - 01.2000
- Maintained database of approximately 20,000 potential study subjects in a Microsoft Access environment.
- Coordinated print, television, and radio advertisements.
- Identified potential study subjects for diabetes, hormone replacement, weight loss, bone density, hypertension, hyperlipidemia and sexual dysfunction clinical trials.
- Developed training guidelines for subject recruitment.
- Consistently met recruitment goals for multiple clinical studies by identifying likely subjects already in patient database which resulted in a reduction of advertising costs.
Patient Advocate Referral Coordinator (Call Center)
United Healthcare Insurance Company
01.1993 - 01.1997
- Answered and monitored multiple telephone lines and initiated medical pre-certification utilizing on-line medical review system
- Educated plan participants of their health plan benefits
- Became lead trainer after six months on the job
Education
Bachelor of Science - Business Administration (Management)
San Diego State University
San Diego, CA01-2000
Skills
- Project Oversight
- Microsoft Office Proficiency
- Budget Management
- Effective Work Organization
- Data collection
- Database management
- Database development
- Basic SQL Understanding
- Medidata RAVE Expertise
- Medrio Trained
Timeline
Associate Director, Data Management
Astute Medical, Inc (bioMerieux)
01.2012 - 07.2024
Manager, Clinical Data Management
Astute Medical, Inc.
12.2009 - 01.2012
Clinical Data Management Consultant
Storm Peak Associates, LLC
05.2009 - 08.2009
Clinical Data Specialist III
Boston Scientific (formerly CryoCor)
01.2005 - 01.2007
Clinical Data Associate II
Boston Scientific (formerly CryoCor)
01.2004 - 01.2005
Clinical Data Associate I
Boston Scientific (formerly CryoCor)
01.2002 - 01.2004
Clinical Data Manager
Boston Scientific (formerly CryoCor)
01.2001 - 01.2009
Temporary Data Entry
Boston Scientific (formerly CryoCor)
01.2001 - 01.2002
Marketing Communication Specialist
VistaInfo Property Disclosure
01.2000 - 01.2001
Subject Recruitment Coordinator
Radiant Research
01.1997 - 01.2000
Patient Advocate Referral Coordinator (Call Center)
United Healthcare Insurance Company
01.1993 - 01.1997
Bachelor of Science - Business Administration (Management)
San Diego State University
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