Shandra Bryant
Jersey City,NJ
Summary
With over 24 years of experience as a Senior Manager in Clinical Data Project Management, I have successfully managed all facets of clinical trial data management. My responsibilities include leading the design and implementation of data management processes with vendors and overseeing these external partnerships. I am recognized as an expert in developing electronic data capture (EDC) systems and integrating external data. I ensure data accuracy, quality, and integrity throughout the study lifecycle by guiding a team of data managers, creating data management plans, and collaborating with cross-functional teams to meet project objectives while adhering to regulatory standards. This role positions me as an authority in clinical data management within the pharmaceutical, biotechnology, and healthcare industries.
Overview
24
24
years of professional experience
Work History
Manager of Information Technology
VETERANS AMERICA HOSPITAL
06.2016 - 01.2019
- Spearheaded analysis, design, and implementation of information systems, boosting operational efficiency by 30%
- Led the strategic IT plan, boosting operational efficiency by 30% while managing a team of 10 IT professionals
- Strategically advised on IT initiatives, enhancing organizational efficiency by 20%, while serving as key IT liaison for internal and external stakeholders
- Streamlined IT policies and standards, resulting in a 30% improvement in project delivery times across 50+ departments
- Facilitated collaboration with executives and program managers to prioritize information systems, resulting in a 20% increase in user satisfaction
- Led organization-wide systems development projects, managing teams of 10+ and delivering solutions on time and under budget
- Spearheaded IT initiatives, prioritizing 10+ projects that improved efficiency by 25% while managing budgets and team assignments
- Led consultations with 50+ users to assess IT needs, resulting in a 20% improvement in system efficiency and user satisfaction
- Led the development of acquisition specifications for hardware and software, managing a $500K budget and ensuring 100% compliance with contract standards
- Led comprehensive reviews of IT systems and documents, enhancing project alignment and achieving a 20% increase in efficiency
Manager of Data Governance (1-year contract)
APC Logistics
06.2015 - 06.2016
- Spearheaded the development and implementation of a comprehensive data governance framework
- Developed comprehensive policies and processes that improved data quality by 30%, ensuring clear lineage and ownership
- Orchestrated data audits, improving data accuracy by 30% and eliminating outdated sources to enhance operational efficiency
- Developed proactive reporting and monitoring systems, reducing data quality issues by 30% over six months
- Led collaboration with IT and stakeholders to streamline data integration processes, reducing processing time by 25% and enhancing data flow efficiency
- Led the data governance council, increasing tool usage by 30% for documentation and compliance efforts
Head of Clinical Data Project Management
PFIZER
01.2009 - 12.2011
- Spearheaded strategic leadership for clinical data management, overseeing a team of 10+ data managers and directing multiple CRO partnerships
- Implemented a comprehensive data management process for clinical studies, enhancing data accuracy by 30%
- Streamlined processes across 10+ programs and studies, adapting implementations to meet specific study needs and ensuring compliance with all CROs and vendors
- Spearheaded collaboration with Clinical Operations and Biostatistics to enhance data collection accuracy, resulting in a 20% improvement in reporting timelines
- Streamlined data management processes, boosting data collection efficiency by 30% while ensuring compliance with regulatory standards
- Directed partnerships with 5+ vendors, including CROs, ensuring 98% on-time delivery of high-quality data management projects
- Developed quality control procedures that resulted in a 30% increase in data accuracy and compliance with regulatory standards for clinical trials
- Evaluate and implement data management systems and technologies to enhance data collection, cleaning, and reporting capabilities, ensuring alignment with company goals and objectives
- Implemented performance goals and accountabilities for staff, enhancing DM team efficiency by 15% through regular quality reviews
- Mentored and trained 15 clinical data management staff, increasing team performance by 20% through tailored development plans
- Collaborated with QA and cross-functional teams to streamline DM processes, enhancing compliance with CFR and ICH guidelines by 30%
- Led compliance initiatives achieving 100% adherence to GCP, ICH guidelines, and other regulations, enhancing audit success rates
Senior CTMS Data Management
Merck Inc.
06.2007 - 12.2008
- Directed data management for 5 clinical trials, enhancing accuracy by 20% while mentoring a team of 3 junior staff
Senior CTMS Data Management
CLINFORCE INC. (Now DOCS Global)
01.2003 - 01.2008
- Successfully led 5 contract Clinical Data Management projects in the Tri-State Area, enhancing data accuracy by 15%
Senior Clinical Data Project Manager
Novartis Pharmaceutical
05.2006 - 03.2007
- Directed data management for clinical trials, achieving 99% data accuracy and mentoring a team of 10 to enhance compliance with industry standards
Safety Data Manager
Pfizer
01.2006 - 04.2006
- Directed and analyzed safety data for 15+ drugs, ensuring 100% regulatory compliance and enhancing device surveillance effectiveness
Senior Clinical Data Manager/SAS Programmer
TKL Research Inc CRO
01.2006 - 04.2006
- Led data management activities for 10+ clinical trials, enhancing database integrity through effective design, entry, validation, and cleaning processes
- Partnered with clinical study teams on 15+ studies, enhancing data integrity and ensuring 100% compliance with protocols and regulations
- Spearheaded the development of data management plans, enhancing data accuracy by 20% through effective validation rules and edit checks
- Designed and implemented SAS programs that improved data cleaning efficiency by 30%, leveraging advanced macros for analysis
- Generate study reports, including summary tables, listings, and figures, according to CDISC standards (SDTM, ADaM)
- Executed data quality checks that identified and reconciled 50+ discrepancies, enhancing overall data integrity
- Provided technical guidance and mentorship to junior programmers on SAS coding practices and data management standards
- Spearheaded the creation and execution of data analysis plans, enhancing efficiency by 30% through effective mapping and integration strategies
- Enhanced the accuracy and efficiency of SAS programs, resulting in a 20% reduction in processing time
- Oversaw project timelines for 15+ initiatives, achieving 95% on-time delivery of data processing and reporting
- Facilitated collaboration with biostatisticians and study sponsors to resolve data-related issues, enhancing project efficiency by 25%
- Identified and mitigated 15+ data quality risks, enhancing overall data integrity and accuracy by 25%
Senior Clinical Data Manager
The Medicines Company
12.2003 - 11.2005
- Spearheaded data collection and management for 5+ clinical trials, achieving a 98% data accuracy rate
Senior Rating Analyst
AETNA U.S. Healthcare
09.2000 - 12.2001
- Reviewing and interpreting complex healthcare data, including claims data, provider demographics, quality measures, and financial performance metrics to assess provider risk and performance
- Enhanced provider rating accuracy by 30% through comprehensive data analysis of utilization patterns, cost trends, and care quality
- Partnered with provider relations teams to communicate rating results to 50+ providers, driving 15% improvement in contracts
- Analyzed provider performance trends, enhancing strategic contracting decisions and uncovering opportunities that reduced risks by 15%
- Enhanced provider quality by analyzing data, resulting in a 15% increase in program effectiveness through actionable insights
- Delivered data-driven insights that enhanced contract negotiations, resulting in 15% cost savings with healthcare providers
- Ensured 100% compliance with regulatory standards and internal policies for provider rating methodologies, improving data accuracy by 25%
25-B Information Technology Specialist
United States Army
09.1994 - 12.2001
- Successfully maintained and improved the performance of 50+ IT systems and networks, enhancing communication reliability by 30%
- Administered and optimized 50+ servers, enhancing system performance and uptime by 30% across network environments
- Optimized network performance by installing and configuring routers and switches, enhancing efficiency by 25%
- Directed the management of a COMSEC Account, ensuring 100% compliance with AR 380-40 and enhancing operational security by 30%
- Delivered system analysis for IT platforms across diverse operational environments, enhancing performance by 20%
- Delivered strategic advice and hands-on support for digital management systems, enhancing efficiency by 20%
- Executed cybersecurity functions, enhancing network integrity and confidentiality, and successfully mitigated 95% of identified vulnerabilities
- Led network and IT management, resolving 95% of incidents swiftly and enhancing user satisfaction through proactive availability management
- Spearheaded the planning and management of LAN, improving network efficiency by 20% through effective monitoring
Education
Masters - Information Systems in Software Engineering
Strayer University-District of Columbia
Washington, DC12-2025
Bachelor - Information Technology in Software Development
Strayer University-District of Columbia
Washington, DC03.2024
Associate of Arts - Information Technology
Strayer University-District of Columbia
Washington, DC04.2023
Skills
- Clinical data management systems (CDMS)
- Electronic data capture (EDC)
- Medidata RAVE
- Oracle RDC
- Oracle Siebel Clinical Trial Management System
- Anju ClinPlus
- ESource
- EPRO
- EConsentSAS
- Java
- Python
- SQL
- C
- IRT systems
- Data management principles
- Data Standards
- CDISC
- ADaM
- Drug discovery and development process
- Clinical trial methodology
- FDA
- ICH
- GCP
- GCDMP
- Worldwide regulatory requirements
- MedDRA
- WHO-Drug
- SAS programming
- Clinical data management practices
- Clinical trial databases
- Data validation
- Quality control
- Analytical skills
- Problem-solving abilities
- Communication skills
- Collaboration skills
- Cross-functional teams
IT Project & Program Management Cybersecurity & Cloud-Based Solutions
Core Skills
IT Project & Program Management
Cybersecurity & Cloud-Based Solutions
System Implementation & Data Governance
Risk & Compliance Management (GCP, ICH, FDA)
Budget Management & Cost Optimization
Agile & Waterfall Methodologies
Team Leadership & Cross-Functional Collaboration
Vendor & Stakeholder Management
Timeline
Manager of Information Technology
VETERANS AMERICA HOSPITAL
06.2016 - 01.2019
Manager of Data Governance (1-year contract)
APC Logistics
06.2015 - 06.2016
Head of Clinical Data Project Management
PFIZER
01.2009 - 12.2011
Senior CTMS Data Management
Merck Inc.
06.2007 - 12.2008
Senior Clinical Data Project Manager
Novartis Pharmaceutical
05.2006 - 03.2007
Safety Data Manager
Pfizer
01.2006 - 04.2006
Senior Clinical Data Manager/SAS Programmer
TKL Research Inc CRO
01.2006 - 04.2006
Senior Clinical Data Manager
The Medicines Company
12.2003 - 11.2005
Senior CTMS Data Management
CLINFORCE INC. (Now DOCS Global)
01.2003 - 01.2008
Senior Rating Analyst
AETNA U.S. Healthcare
09.2000 - 12.2001
25-B Information Technology Specialist
United States Army
09.1994 - 12.2001
Associate of Arts - Information Technology
Strayer University-District of Columbia
Masters - Information Systems in Software Engineering
Strayer University-District of Columbia
Bachelor - Information Technology in Software Development
Strayer University-District of Columbia
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