George F. Maldonado
Princeton,USA
Summary
Hardworking Associate Director of Data Integration with extensive knowledge of various aspects of the Clinical Development industry. Adept at supporting and enhancing operations with a decisive and positive leadership style and strategic approach to decision making. Offering 27 years of experience in data processing, EDC programming, data integration, CTMS and oversight of global and international teams.
Overview
28
28
years of professional experience
Work History
Associate Director, Technology Enablement
LabCorp/ Fortrea Clinical Development Services
06.2021 - Current
- Lead Data Integrator team which handles metadata mapping to integrate EDC data via automation to CTMS for Clinical, Grant Payments and Informatics utilizing the Rave Web services and ODM data
- Participate in the Seibel/Veeva CTMS design and specification meetings as well as UAT and Validation
- Participate in the assessment of the project specific CRF study design of EDC and IVR data and Seibel/Veeva CTMS (Medidata RAVE, Oracle Inform, third party EDC / IVR vendors) to ensure compliance with Siebel CTMS import requirements and standards
- Partner with IT technical staff and Siebel/Veeva CTMS technical staff to schedule project imports and to assess the impact of any planned software updates or functionality changes
- Work with the Grants team to Align automated integration between Siebel/Veeva CTMS and Grants payments
- Manage the assessment Metadata mapping requirements for project specific data for integration purposes
- Collaborate with internal and external clients to understand client system requirements as well as data requirements
- Conduct project specific quality control checks during and after CRF Design is completed to conform with Standards
- Participate in the ongoing review of the EDC/IVR processes to ensure defined import standards between the systems are being followed
- Maintain strong relationship with EDC /IVR, and COE departments to stay abreast of any changes to defined standards being planned within the departments
- Work closely with UAT Team and CTMS project team to confirm all database design structures are correct and acceptable for data integrations into CTMS
- Manage the Seibel/Veeva CTMS support for troubleshooting missing data trends and bug fixes that are required for missing data issue resolution
- Lead the Data Integration team to assist with complicated integration designs and advise in regards to system functionality issues that need to be escalated.
- Improved overall team efficiency by streamlining project management processes and implementing new collaboration tools.
- Managed cross-functional teams for multiple large-scale projects, successfully completing each on time and within budget constraints.
- Enhanced employee performance through targeted training programs and regular feedback sessions, resulting in higher productivity levels.
- Implemented data-driven decision-making strategies, leading to more informed business choices and positive outcomes.
- Mentored junior staff members, providing guidance on professional development opportunities and career progression paths within the company.
- Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
- Assisted senior leadership in managing all aspects of operations.
- Led teams of up to 9 personnel, supervising daily performance as well as training and improvement plans.
- Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
- Engaged analytical subject matter experts outside project teams to drive troubleshooting of critical process-related deviations and enhance process improvements.
- Worked closely with management to provide effective assistance for specific aspects of business operations.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
Manager, Data Integrators
Covance Clinical Development Services
12.2019 - 06.2021
- Managed, mentor, train and build the Data Integration team
- Subject Matter expert on set up of Subject Visit template, Rave Web Services calls and metadata mapping to integrate real time data with Siebel CTMS
- Participated in new systems review, rollout and testing
- Participated in the assessment of the project specific CRF study design of EDC and IVR data (Medidata RAVE, Oracle Inform, third party EDC / IVR vendors) to ensure compliance with CTMS import requirements and standards
- Worked with the Grants team to Align CTMS and Grants payment budgets
- Assessed field mapping requirements for project specific trial data for import purposes
- Worked with client contact to understand client system requirements as well as data requirements
- Conducted project specific quality control checks during and after CRF Design is completed
- Participated in the ongoing review of the EDC/IVR processes to ensure defined import standards between the systems are being followed
- Maintained strong relationship with EDC /IVR, and COE departments to stay abreast of any changes to defined standards being planned within the departments
- Notified management of deviations from defined process standards
- Worked with EDC/IVR and COE to refine or update standards as needed to meet the businesses needs
- Worked closely with UAT Team and CTMS project team to confirm all database design structures are correct and acceptable for data imports into CTMS
- Worked closely with IT technical staff and CTMS technical staff to schedule project imports and to assess the impact of any planned software updates or functionality changes.
- Increased team productivity by implementing streamlined processes and effective communication strategies.
- Achieved departmental goals by developing and executing strategic plans and performance metrics.
Data Integrator
Covance Clinical Development Services
09.2013 - 12.2019
- Set up Subject Visit template, Rave Web Services calls and metadata mapping to integrate real time data with Siebel CTMS
- Participated in the assessment of the project specific CRF study design of EDC and IVR data (Medidata RAVE, Oracle Inform, third party EDC / IVR vendors) to ensure compliance with CTMS import requirements and standards
- Worked with the Grants team to Align CTMS and Grants payment budgets
- Assessed field mapping requirements for project specific trial data for import purposes
- Worked with client contact to understand client system requirements as well as data requirements
- Conducted project specific quality control checks during and after CRF Design is completed
- Participated in the ongoing review of the EDC/IVR processes to ensure defined import standards between the systems are being followed
- Maintained strong relationship with EDC /IVR, and COE departments to stay abreast of any changes to defined standards being planned within the departments
- Notified management of deviations from defined process standards
- Worked with EDC/IVR and COE to refine or update standards as needed to meet the businesses needs
- Worked closely with UAT Team and CTMS project team to confirm all database design structures are correct and acceptable for data imports into CTMS
- Worked closely with IT technical staff and CTMS technical staff to schedule project imports and to assess the impact of any planned software updates or functionality changes.
Clinical Applications Programmer 2
Covance Clinical Development Services
09.2011 - 09.2013
Clinical Applications Programmer
Covance Clinical Development Services
01.2009 - 09.2011
Coordinator, Clinical Data Processing
Covance Clinical Development Services
12.2007 - 01.2009
Clinical Data Processor 2
Covance Clinical Development Services
01.2003 - 01.2007
Assistant, Electronic Publishing
Covance Clinical Development Services
01.2002 - 01.2003
Document Management Assistant
Covance Clinical Development Services
01.2000 - 01.2002
Senior Project Support Specialist
Covance Clinical Development Services
01.1999 - 01.2000
Project Support Specialist
Covance Clinical Development Services
01.1996 - 01.1999
Education
South Brunswick High School
Monmouth Junction, NJMedidata Rave Certified
Medidata Train The Trainer
Skills
- Medidata Rave
- Siebel/Veeva CTMS and Integrations
- Veeva Quality Docs
- SQL Developer
- Grant Payment Functionality
- Strategic Leadership
- Technical Implementation
- Database Management
- MS Office
- Coaching and Mentoring
- Team Collaboration and Leadership
- Database Development
- Performance Evaluations
- Data Analysis
- Client Relationship Management
- Performance Management
- Task Delegation
- Staff Development
- Systems Development
- Database Coordination
- Cross-functional Collaboration
- Employee Development
- Process Improvement
Timeline
Associate Director, Technology Enablement
LabCorp/ Fortrea Clinical Development Services
06.2021 - Current
Manager, Data Integrators
Covance Clinical Development Services
12.2019 - 06.2021
Data Integrator
Covance Clinical Development Services
09.2013 - 12.2019
Clinical Applications Programmer 2
Covance Clinical Development Services
09.2011 - 09.2013
Clinical Applications Programmer
Covance Clinical Development Services
01.2009 - 09.2011
Coordinator, Clinical Data Processing
Covance Clinical Development Services
12.2007 - 01.2009
Clinical Data Processor 2
Covance Clinical Development Services
01.2003 - 01.2007
Assistant, Electronic Publishing
Covance Clinical Development Services
01.2002 - 01.2003
Document Management Assistant
Covance Clinical Development Services
01.2000 - 01.2002
Senior Project Support Specialist
Covance Clinical Development Services
01.1999 - 01.2000
Project Support Specialist
Covance Clinical Development Services
01.1996 - 01.1999
South Brunswick High School
Medidata Rave Certified
Medidata Train The Trainer
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