Gina Jimenez
Summary
To obtain a professional position in the biotechnology field which will draw upon my vast knowledge and experience.
Overview
31
31
years of professional experience
Work History
Project and Data Manager
AstraZeneca
01.2024 - 08.2024
- Manage contracting with third-party lab service providers for flow cytometry assay development and validation
- Assist with appropriate contracting of flow cytometry assays for clinical analysis
- Support complex and highly active studies, as assigned
- Independently troubleshoot issues encountered and provide guidance to junior level peers
Specialist, Integrated Bioanalysis
AstraZeneca/Medimmune, LLC
06.2017 - 12.2023
- Followed all company policies and procedures to deliver quality work.
- Developed strong client relationships through consistent communication and attentive service.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
- Interpreted clients' needs and introduced services to fit specific requirements.
Clinical Data Coordinator I/II
MedImmune, LLC
01.2013 - 06.2017
- Collaborated with cross-functional teams to ensure timely completion of clinical trials.
- Conducted regular audits on clinical trial databases to identify potential issues and implement necessary corrective actions.
- Contributed to the successful completion of multiple high-profile clinical trials by staying organized and focused under pressure.
- Resolved data discrepancies through meticulous investigation and collaboration with relevant departments.
Data Entry Associate (Aerotek)
Medimmune, LLC
09.2009 - 01.2013
- Entering data from a lab requisition form into a proprietary database
- Manual verification- line by line verification of other staff's data entry to ensure that correct information has been entered
- Create manual discrepancies to send to the site
- Follow up with sites regarding outstanding discrepancies
- File requisition forms in binders in Accession number order
- File discrepancies in designated area/order
- Discrepancy Management: Creating, reissuing, resolving discrepancies.
Associate, Clinical Data Specialist
Medtronic Inc.
06.2008 - 06.2009
- Participates in the review of Clinical research documents (e.g
- Protocols, Case Report Forms, reports and statistical analysis)
- Participate in study trial team meetings representing data management
- Participate in conference calls and/or meetings with vendors
- Assist in implementation and training of Clinical database system
- Provide Clinical data management support to Clinical Operations teams and Clinical Data Manager
- Develop and/or provide input on clinical trial data specifications, including eCRF design, database requirements, edit rules/checks, and data validations
- Meet regularly with Manager, CDM to discuss and seek innovative strategy and resolution to data management issues
- Support the Medtronic/Kyphon Quality Policy and Quality System
- Track, report status and progress of data management for allocated trials to Clinical Data Manager.
Clinical Data Coordinator
Medtronic Inc.
03.2008 - 06.2008
- Provide Clinical data management support to Clinical Operations teams and Clinical Data manager
- Discrepancy Management
- Attend weekly study meetings.
Legal Assistant
Alza Corporation/Kelly Services
11.2007 - 03.2008
- Process and send letters to agents informing them which cases have been abandoned or transferred to another company
- Reporting of Assignments
- Upload Legal documents in First to File
- Research Legal cases using Memo Tech
- Complete multiple tasks requested by Senior Attorneys.
Clinical Data Manager (Acting Role)
Alza Corporation
04.2007 - 08.2007
- Coordinates data flow to meet study timelines
- Attends weekly study meetings
- Serves, Clinical Data Manager services under the direction of the Lead Data Manager
- Meets objectives as assigned, interacts with the clinical data management staff and other project team members to resolve project issues and provide status information
- Scans, Index and enters any incoming data in the specified database
- Performs data audits
- SAE Reconciliation
- Issue and resolve discrepancies.
Clinical Data Associate (Acting Role)
Scios/Alza Corporation
09.2006 - 04.2007
- Supporting Data Management Leads in discrepancy review and discrepancy resolution
- Review data discrepancies generated by the system and confirm whether the discrepancy is caused by a data entry error or an issue with the actual data needs to be resolved
- Resolve any discrepancies that are a result of a data entry error by updating the clinical database per the correct data on the Case Report Form
- Resolve any discrepancies that may be handled internally (i.e
- Without a query) per the Data Management plan
- Generate data queries ready to be sent to clinical investigator's when data issues need further clarification or resolution
- Review returned and answered data queries to ensure appropriate answers and then updates the clinical database accordingly
- Re-issue queries if issue is still unresolved or needs further clarification.
Lead, CRF Processing
Scios, Inc.
05.2005 - 09.2006
- Responsible for the hiring and supervising all data entry, data verification, filling and Clinical Records Coordinator staff within Clinical Data Management
- Supervising both temporary and permanent Data Entry and Clinical Records staff
- Manage workloads and priorities to ensure timelines are met
- Performs data entry, verification, filling, scanning, indexing printing and/or CRF binder building
- Ensure imaging system is on-line and being used appropriately
- Coordinate or participate with database and image audits
- CRF and DCF scanning and indexing
- Process all incoming Case Report Forms and Data Clarification Forms
- Logged all Data Clarification Forms to receive in the clinical database
- Create transmittals for all Data Clarification Forms being sent out to the sites
- Update the imaging database as requested by the Clinical Data Associate
- Run weekly reports to ensure all CRF's have been 1st and 2nd entered
- Weekly one on ones with Data Entry and Clinical Records staff.
Clinical Data Entry
Scios Inc (Kelly Services)
12.2004 - 05.2005
- Prepared Case Report Forms for indexing and scanning
- Performs 1st and 2nd entry
- Ran and cleaned verification report from 1st and 2nd entry
- Verified the clinical database discrepancies
- Tested the database screens before being released into production.
Data Entry Operator
Amgen Inc. (Formerly Tularik Inc.)
03.2003 - 11.2004
- Prepared Case Report Forms for tracking
- Tested and Validated study specific data entry screens for clinical databases prior to being released into production
- Performed verification for 1st and 2nd entry and made needed corrections to the data entry databases
- Performed 1st and 2nd entry to meet timelines
- Data Clarification Forms tracking and preparation of transmittal letters for Data Clarification Forms that were sent to the sites
- Submitted database change request forms to programmer to facilitate changes to databases already in production
- Mentored and trained new Data Entry personnel
- Updated the clinical databases with modifications and corrections resulting from the data entry correction forms
- Audited different studies for closeout.
Data Administrator Coordinator
Quintiles Pacific
02.1994 - 12.2001
- Test data entry screens to ensure that all data fields for Case Report Forms data are captured in the study databases
- Document and resolve data problems
- Obtain or provide to/from other team members as needed to complete responsibilities
- Develop and maintain good communication and working relationships with the clinical data management team
- Coordinates and ensures data entry and verification/comparison are carried out in accordance with data entry instructions
- Coordinates and ensures CRF's are processed, logged, and tracked in accordance with CRF processing instructions
- Meets objectives as assigned, interacts with the clinical data management staff and other project team members to resolve project issues and provide status information
- Provides instructions and mentoring for clinical data services staff, assist in the maintenance project files and documentation in cooperation with project lead and lead designee
- Cooperate with lead data manager and management to ensure timely completion of project tasks
- Produce and/or review data tracking and data entry guidelines in cooperation with the clinical data manager project lead or lead designee
- Serves as clinical data services functional lead representing the clinical data services under the direction of the lead data manager.
Education
Vital signs, Medical Terminology, Draw blood -
Sawyer College/Medical Asst.
San Jose, Ca01.1993
High School Diploma/General Education -
Silver Creek High School
San Jose, Ca01.1991
Skills
- 10 Key by touch
- Microsoft Word
- Oracle Clinical
- Clintrial 33 & 43
- Microsoft Excel
- CRF Work Manager
- Discrepancy Management System (DMS)
- Medidata Rave (EDC)
- SDMS (Sample and Data Management System)
- Laboratory Information Management System
Timeline
Project and Data Manager
AstraZeneca
01.2024 - 08.2024
Specialist, Integrated Bioanalysis
AstraZeneca/Medimmune, LLC
06.2017 - 12.2023
Clinical Data Coordinator I/II
MedImmune, LLC
01.2013 - 06.2017
Data Entry Associate (Aerotek)
Medimmune, LLC
09.2009 - 01.2013
Associate, Clinical Data Specialist
Medtronic Inc.
06.2008 - 06.2009
Clinical Data Coordinator
Medtronic Inc.
03.2008 - 06.2008
Legal Assistant
Alza Corporation/Kelly Services
11.2007 - 03.2008
Clinical Data Manager (Acting Role)
Alza Corporation
04.2007 - 08.2007
Clinical Data Associate (Acting Role)
Scios/Alza Corporation
09.2006 - 04.2007
Lead, CRF Processing
Scios, Inc.
05.2005 - 09.2006
Clinical Data Entry
Scios Inc (Kelly Services)
12.2004 - 05.2005
Data Entry Operator
Amgen Inc. (Formerly Tularik Inc.)
03.2003 - 11.2004
Data Administrator Coordinator
Quintiles Pacific
02.1994 - 12.2001
Vital signs, Medical Terminology, Draw blood -
Sawyer College/Medical Asst.
High School Diploma/General Education -
Silver Creek High School
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