Gina Jimenez
San Jose,CA
Summary
Diligent Clinical Data Manager with robust background in data management. Proven track record of organizing, storing, and analyzing large datasets effectively. Demonstrates strong analytical thinking and attention to detail.
Overview
31
31
years of professional experience
Work History
Project and Data Manager, Integrated Bioanalysis
AstraZeneca
01.2024 - 08.2024
- Assist AZ clinical trials with appropriate contracting operations for clinical flow testing during study startup and designated amendments made during the life of a study
- Attend routine weekly and/or bi-weekly scheduled study meetings with both internal & external study team members
- Review and provide comments to study documents provided by the central labs prior to finalization (Central Laboratory Requirements, Laboratory Specifications Document, Scope of Work, Requisition forms, Project Management Plan, Work Orders, LES/LTR, Proposed Study Budget and Lab Manual)
- Coordinate with clinical trial teams and third-party lab service providers to review, edit, and finalize documents for delivery of the required lab services to ensure study timelines are met
- Work with data programmers to drive the delivery of data transfer specifications and the associated data
- Monitor Whole Blood and Bone Marrow sample receipt in preparation for flow testing throughout the life of a study to verify accurate sample collection
- Coordinate with clinical trial teams and third-party lab service providers to review, edit, and finalize documents for delivery of the required lab services and ensure study timelines are met
- Coordinate with third-party vendors and Translational Medicine Scientists to ensure the availability of preliminary data for interim analyses (e.g.: for Safety Review Committee Meetings)
- Flag inconsistencies within patient data during data reconciliation to deliver clean datasets for interpretive analysis
Specialist, Data Management, Integrated Bioanalysis
AstraZeneca (Additional Responsibility)
01.2013 - 08.2024
- Company Overview: Formally Medimmune, LLC
- Perform data review and logic checks, issue queries to sites, central laboratories, monitoring CROs, and/or Clinical Operations and applying updates to the internal Laboratory Information Management System (LIMS) database as identified through query resolution and data review
- Attend routine weekly and/or bi-weekly scheduled study meetings with both internal (Clinical Operations, Programming, Biostats, AstraZeneca internal Labs and/or Biobanks) & external (CROs, Central Labs) cross-functional study team members
- Provide routine header (samples received + demographic data) and production (Samples tested + reported results) data transfers to the designated study stakeholders according to data transfer specifications (DTS) to ensure data delivery timelines are met
- Review and provide comments to required study documents provided by the central labs prior to finalization (Scope of Work, data transfer roster file & Protocol Specific Addendum) and receipt of the first sample shipments
- Manage multiple high priority (phase I/II/III) oncology study start-up to study close-out (Key Disease areas: Majority of Solid Tumor; Durvalumab non-small cell lung cancer, Durvalumab Gallbladder cancer, Breast Cancer, Liver Cancer, Pancreatic Cancer, advanced Renal Cell Carcinoma & Relapsed or Refractory Classical Hodgkin Lymphoma)
- Manage multiple high priority (phase I/II/III) Cardiovascular, Renal and Metabolism study start-up to study close-out (Key Disease area: Heart Failure and Pulmonary Hypertension)
- Manage multiple high priority (phase I/II/III) Respiratory and Immune Therapies study start-up to study close-out (Key Disease areas: Asthma & Chronic Obstructive Pulmonary Disease (COPD)
- Reconcile data on a monthly and/or ad-hoc basis between multiple data sources (Medidata Rave (EDC), Laboratory Information Management System (LIMS) and Central Lab databases) updating internal database based on reconciliation findings per study team requests to ensure clean data is delivered
- Independently troubleshoot issues encountered and provide guidance to junior level peers
- Follow corporate (e.g., SOP's) and regulatory requirements (e.g., GCP) and proactively manage studies, following such guidelines and requirements
- Review and upload received data transfer roster files from the corresponding Central Labs containing samples included within a particular received shipment
- Upload Subject Statuses to internal database provided within the study Enrollment/Cohort trackers to ensure Screen Fail subjects are excluded from sample pulls in preparation for Analysis testing
- Partake in study Data Transfer Specification (DTS) reviews to ensure that the expected internal demographic & reported result data is exported within internal database per specified required study datasets
- Perform study closeout tasks, data cleaning/query resolution prior to Database lock
- Performed Laboratory Information Management System (LIMS) User Acceptance Testing (UAT) for modifications as needed
- Formally Medimmune, LLC
- Followed all company policies and procedures to deliver quality work.
Data Entry Associate, Clinical Sample & Data Management
Medimmune, LLC
09.2009 - 01.2013
- Entering data from a lab requisition form into Sample and Data Management System (SDMS) database
- Manual verification – line by line verification of other staff’s data entry to ensure that correct information has been entered into internal database
- Create manual discrepancies in preparation to send to site(s)
- Follow up with sites regarding outstanding discrepancies
- Manually file requisition & discrepancy forms in corresponding study binders in designated order
- Partake in routine Discrepancy Management: Creating, reissuing and resolving discrepancies
- Sorted documents and maintained organized filing process.
Associate, Clinical Data Specialist, Clinical Data Management
Medtronic, Inc.
06.2008 - 06.2009
- Participate in study trial team meetings representing Data Management
- Participate in the review of clinical research documents (e.g.., Protocols, Case Report Forms, audit reports and statistical analysis)
- Provide clinical data management support to clinical operations team and assigned clinical data manager
- Partake in routine Discrepancy Management: Creating, reissuing and resolving discrepancies
- Develop and/or provide input on clinical trial data specifications, including eCRF design, data requirements, edit rules/checks and data validations
- Met regularly with Manager, Clinical Data Management to discuss and seek innovative strategy and resolution to data management issues
- Partake in routine Discrepancy Management: Creating, reissuing and resolving discrepancies
- Attend weekly study meetings
- Provide clinical data management support to clinical operations team and assigned clinical data manager
- Trained junior staff members on best practices for clinical data management, contributing to a more knowledgeable team.
Legal Assistant
Alza Corporation
11.2007 - 03.2008
- Company Overview: Kelly Services
- Process and send letters to agents informing them which cases have been abandoned or transferred to another company
- Reporting of Assignments
- Upload Legal documents to First to File system
- Research Legal cases using Memo Tech system
- Complete multiple requested tasks requested by Senior Attorneys
- Kelly Services
- Facilitated timely resolution of legal matters by preparing and organizing essential documents.
Clinical Data Manager (Acting Role), Clinical Data Management
Alza Corporation
04.2007 - 08.2007
- Coordinate the data flow to meet study timelines
- Attend regular weekly study meetings to ensure study timelines are met
- Scans, Index and enters any incoming CRF data to designated database
- Performed in SAE reconciliation
- Partake in routine Discrepancy Management: Creating, reissuing and resolving discrepancies
- Meets objectives as assigned, interacts with the clinical data management staff and other project team members to resolve project issues and provide status information
- Performed thorough review of clinical protocols to identify potential risks or inconsistencies in study design.
Clinical Data Associate (Acting Role), Clinical Data Management
Scios Inc./Alza Corporation
09.2006 - 04.2007
- Partake in routine Discrepancy Management: Creating, reissuing and resolving discrepancies
- Resolve discrepancies that are a result of data entry error(s) by updating the clinical database per the correct data per Case Report Forms.
- Monitored clinical trial progress closely, identifying potential risks or delays early on for swift intervention.
- Collaborated with cross-functional teams, fostering strong working relationships for seamless project execution.
- Without an issued query) per Data Management Plan
- Re-issue/follow-up on queries if discrepancies are still unresolved or needs further clarification
Lead, CRF Processing, Clinical Data Management
Scios Inc.
05.2005 - 09.2006
- Responsible for the hiring and supervising all data entry, data verification, filing 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 study timelines are met
- Weekly one on ones with Data Entry and Clinical Records staff
- Perform data entry, verification, filing, CRF/DCF scanning, indexing printing and Study binder building
- Run weekly reports to ensure all Case Report Forms have been 1st and 2nd entered
- Update the imaging database as requested by the Clinical Data Associate
- Create transmittals for all Data Clarification Forms being sent out to the sites
- Logged all received Data Clarification Forms into the Clinical database
- Process (Scanning/Indexing) all incoming Case Report Forms and Data Clarification Forms
- Coordinate and/or participate in database and image audits
- Worked effectively in fast-paced environments.
- Self-motivated, with a strong sense of personal responsibility.
Clinical Data Entry, Clinical Data Management
Scios Inc.
12.2004 - 05.2005
- Company Overview: Kelly Services
- Perform 1st and 2nd pass entry
- Prepared Case Report forms for indexing and scanning
- Ran and cleaned verification report from 1st and 2nd pass entry
- Verified the clinical database discrepancies
- Tested and Validated study specific data entry screens for clinical database prior to being released in production
- Kelly Services
- Proven ability to learn quickly and adapt to new situations.
Data Entry Operator, Clinical Data Management
Amgen Inc. (Formally Tularik, Inc.)
03.2003 - 11.2004
- Company Overview: Formally Tularik Inc
- Prepared Case Report Forms for tracking
- Performed verification for 1st and 2nd pass entry to meet timelines
- Updated the clinical databases with modifications and corrections resulting from the data entry correction forms
- Submitted database change request forms to programmers to facilitate change to databases already in production
- Audited assigned studies for study closeout
- Developed and implemented data entry operations.
- Conducted audits of existing data entry processes.
Data Administrator Coordinator, Clinical Data Management
Quintiles Pacific
02.1994 - 12.2001
- Test data entry screens to ensure that all data fields for Case Reports Forms data are captured in the study database
- 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/comparisons 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 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
Medical Assisting -
Sawyer College
01.1993
Skills
- Medidata Rave Expertise
- Excel Proficiency
- Discrepancy Management
- Conduct Regular Data Reconciliation
- Efficient Typing Ability
- Implement Routine Data Quality Checks
- Data Quality Assurance
- Team Leadership Skills
- Strong Verbal Communication
- LIMS (Laboratory Information Management System)
- Clinical Analytics (Q2 Solutions)
- SDMS (Sample and Data Management System)
- Critical Thinking Ability
- Effective Time Management
- Smartsheet Project Management
- SharePoint Content Oversight
- Technical Troubleshooting
- Data cleansing
- Data quality assurance
- Data Quality Audits
- Collaborative Team Player
- Analytical Problem-Solving
- Attention to detail
- Time management
- Multitasking
- Excellent communication
- Critical thinking
Timeline
Project and Data Manager, Integrated Bioanalysis
AstraZeneca
01.2024 - 08.2024
Specialist, Data Management, Integrated Bioanalysis
AstraZeneca (Additional Responsibility)
01.2013 - 08.2024
Data Entry Associate, Clinical Sample & Data Management
Medimmune, LLC
09.2009 - 01.2013
Associate, Clinical Data Specialist, Clinical Data Management
Medtronic, Inc.
06.2008 - 06.2009
Legal Assistant
Alza Corporation
11.2007 - 03.2008
Clinical Data Manager (Acting Role), Clinical Data Management
Alza Corporation
04.2007 - 08.2007
Clinical Data Associate (Acting Role), Clinical Data Management
Scios Inc./Alza Corporation
09.2006 - 04.2007
Lead, CRF Processing, Clinical Data Management
Scios Inc.
05.2005 - 09.2006
Clinical Data Entry, Clinical Data Management
Scios Inc.
12.2004 - 05.2005
Data Entry Operator, Clinical Data Management
Amgen Inc. (Formally Tularik, Inc.)
03.2003 - 11.2004
Data Administrator Coordinator, Clinical Data Management
Quintiles Pacific
02.1994 - 12.2001
Medical Assisting -
Sawyer College
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