Carlos Salazar
Simi Valley,USA
Summary
Accomplished Director at Exelixis Inc., Seasoned professional in general and operations management with comprehensive experience leading teams, optimizing processes, and implementing cost-effective strategies. Skilled in strategic planning, staff development, and operational efficiency, consistently improving workflow and reducing costs. Proven track record of enhancing overall business performance through effective leadership and innovative problem-solving.
Overview
30
30
years of professional experience
Work History
Director, EClinical Solutions
Exelixis Inc.
Alameda, CA
01.2019 - Current
- Responsible for managing the Clinical Systems and Data Management team.
- Improved productivity initiatives, managing budgets and accounts, coordinating itinerary and scheduling appointments.
- Partnered with staff to create professional development plans to support personal and business growth.
- Collaborated with senior leadership to set long-term objectives for the company.
- Enhanced customer satisfaction through the development of service improvement initiatives.
- Cultivated strong relationships with customers by responding promptly to inquiries or complaints.
- Negotiated high-value contracts with vendors and partners to optimize resource allocation.
- Analyzed data to inform decision-making and strategic direction.
- Coordinated activities with other departments to expedite work and improve collaboration.
- Developed and implemented strategic plans to ensure organizational goals were met.
- Identified opportunities for improvement in operational performance metrics.
- Mitigated business risks by working closely with staff members and assessing performance.
- Represented the organization at industry events, conferences, and public meetings.
- Negotiated agreements with external partners such as contractors or consultants.
- Conducted regular meetings with department heads to review progress on strategic initiatives.
- Led cross-functional teams to drive project completion within budget and deadlines.
Manager, Clinical Systems and Data Management
Edwards LifeSciences Inc.
12.2015 - 12.2018
- Responsible for managing the TMTT Business Unit, Data Management, Clinical Programming and Validation Group
Senior Systems Analyst
Biosense Websters
11.2014 - 11.2015
- Responsible for managing clinical trial database design and build
Clinical Data Management Systems Manager
Amgen Inc
07.2014 - 10.2014
- Functional lead for Early Development and Oncology CDM Systems
- Started the CDM Systems team that supports Clinical Trials for Database Build and Integration
- Business owner of clinical systems technology (Medidata RAVE and Oracle Inform)
- Managing FSP Database Programming team
- Managing FSP Clinical Reporting team
- Managing FSP Electronic Data Specialist team
- Managing Study Startup team
- Managing Database Administration Team
- Subject Matter Expert for any aspect of CDM Systems
- Implemented a company wide Data Transfer Automation using Secure File Transfer Protocol
- Authored and implemented CDM Systems Database Build SOP, Guidelines and Work Instructions
- Authored and implemented Clinical Reporting SOP, Guidelines and Work Instructions
- Authored and implemented CODING SOP, Guidelines and Work Instructions
- Authored and implemented Data Transfer Automation SOP, Guidelines and Work Instructions
- Lead the cross functional team in the validation of Data Transfer Automation Project
- Lead the cross functional team in the validation of RAVE Coder Enablement Project
- Formed the support team for Data Management, Clinical Systems and Validation group
- Managing Data Management, Clinical Systems and Validation activities
- Subject Matter Expert for Database Design and Integration using Medidata RAVE (Rave Architect, Custom Function, CTMS, RTSM, RAVE Coder and B04 reports)
- Created and implemented the process for Clinical Trial Reporting
- Implemented the database migration process to support post-production database updates
- Established and implemented the Database Build process
- Created SharePoint for TMTT Biometrics and Design workflow for any service related and reporting needs
- Primary representative of Biometrics to Corporate SOP standardization process
- Serves as main database administrator for all RAVE studies
- Responsible for successful pilot of Database Specification and Tracking Worksheet
- Responsible for design, build and maintenance of clinical trials using Medidata RAVE
- Responsible for integration of Medidata RAVE studies to Bioclinica CTMS
- Team member of the Veeva System Implementation
- Design the workflow, setup and implemented a tool using SharePoint for database update request
- Serve as an SME for Custom Function programming for sister company of J&J
- Serves as main database administrator for all RAVE studies
- Managing the group responsible for all operational aspects of database build and maintenance of all Early Development and Oncology therapeutic area
- Responsible for the design, build and implementation of eSDM (Electronic Study Definition Matrix) using IBM Cognos
- Responsible for the design, build and implementation of Clinical Trial Work Request Tool using SharePoint
Systems Analyst Programmer
Vega Consulting
09.1994 - 12.1995
- Part of the programming team stationed in Columbia South Carolina that worked on South Carolina Child Support Tracking Systems
- Systems Lead responsible for design, programming, and implementation of the tracking module on SC Child Support System using Informix and Unix scripting
- Responsible for training the local government employees on South Carolina Child Support System Tracking Module
Education
Bachelor of Science - Business Administration, Business Management
University of the East
Manila, Philippines10.1989
Skills
- PUBD process implementation
- Vendor management
- Vendor selection
- Line listing tool design
- Oracle Clinical Database
- BrioQuery
- EDC platform identification
- Medidata RAVE
- Study design
- Y2K upgrade
- Clinical Systems application
- Clinical Trial databases
- Medidata RAVE Study Builder
- RSG
- RAVE Coder
- Medidata Payment
- TSDV
- EPRO integration
- IRT integration
- Oracle Inform
- C
- C#
- Custom Function
- SAS JMP
- JSCAPE Administration
- Trigger setup
- Multitasking and organization
- Staff management
- Performance management
- People management
- Conflict resolution
- Vendor relationship management
- Strategic planning
- Talent acquisition
- Team collaboration
Timeline
Director, EClinical Solutions
Exelixis Inc.
01.2019 - Current
Manager, Clinical Systems and Data Management
Edwards LifeSciences Inc.
12.2015 - 12.2018
Senior Systems Analyst
Biosense Websters
11.2014 - 11.2015
Clinical Data Management Systems Manager
Amgen Inc
07.2014 - 10.2014
Systems Analyst Programmer
Vega Consulting
09.1994 - 12.1995
Bachelor of Science - Business Administration, Business Management
University of the East
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