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)
San Diego, CA
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.
San Diego, CA
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
Carlsbad, CA
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)
San Diego, CA
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)
San Diego, CA
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)
San Diego, CA
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)
San Diego, CA
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)
San Diego, CA
01.2001 - 01.2002
- Performed data entry for all US and European clinical trials
Marketing Communication Specialist
VistaInfo Property Disclosure
San Diego, CA
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
San Diego, CA
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
San Diego, CA
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