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
South San Francisco, CA
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
South San Francisco, CA
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
Mt.View, Ca
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
Mt. View, Ca
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