- Deep expertise at the intersection of Cancer clinical trials and Clinical data management and Project Management
- Recognized Project and Program Manager with successful experience improving and managing clinical information systems.
- Focus on end - to-end solutions development and deployment, from strategy design and presentation to influencing multiple levels across cross-functional divisions, achieving results on time and within budget.
Databases: Oracle, SQL Server, MySQL
Analysis / Reporting: Business Objects, SQL Server reporting service, Qlikview
Project Management: MS Project, JIRA, Clarity
Senior Project Manager - Consultant - Applications and Data
- Managing end-to-end project with budget of $1.5MM as a part of the overall program to improve operational efficiencies to support clinical trials across the organization - targeted Confidential of $10MM
- Managing a 9 member cross-functional team for Analytical risk based monitoring (ARBM) initiative to facilitate targeted source documentation validation and optimize on-site monitoring
- Managing the vendor SLAs and serve as vendor liaison.
- Partnering with the clinical operations and finance community to establish program management methodology towards large programs that would improve the predictability of large multi-million dollar programs
Confidential, Minneapolis, MN
Senior Clinical Data Manager - CTMS Administrator
- People Manager - Lead a team of direct reports to conceptualize and deploy Clinical Trials Management Systems (OnCore) across the enterprise, including Oncology, Cardiology and Public Health working closely with regulatory, finance and clinical function partners.
- Interacted with Executive Leadership at Cancer Center and Enterprise IT, to address issues related to clinical information systems and data management.
- Designed IT and Data Management SOPs for regulated systems and data sharing agreements partnering with IT and Clinical Research Office.
- Managed day to day CTMS needs, data management and production support including help desk for the Cancer Center.
- Designed manuals and conducted extensive for data managers and regulatory managers across multiple modules and multiple therapeutic areas.
Confidential, Chicago, IL
Project Leader - Clinical Informatics
- Promoted to Project Leader for Velos, eResearch System implementation, facilitating development of clinical trials eResearch applications to ensure HIPAA compliance, while improving data quality and access for physicians and regulatory managers.
- Managed university’s eResearch for electronic case report form submission for Cancer Center, supporting more than 100 users, more than 30,000 patients, and 200 open clinical trials
- Led cross-functional team of 10 across cancer center executive leadership, IT and clinical research to define parameters and implement standard clinical trials systems package across the university’s biological sciences divisions.
- Guided team in streamlining and standardizing clinical trials data; CDISC standards, and facilitating system entry for Internal Review Board (IRB) submissions and NCI regulations to promote ease in accessing information and reporting data to any federal agency.
- Spearheaded initiative with clinical trials offices to develop and drive process for internal audits for patient medical record reviews and monitoring; designed SOPs to improve adherence to IRB protocols.
Confidential, Toledo, OH
Manager - Web Services
- Supervised a team of 4 direct reports and managed full project lifecycle to produce and promote the online content management system, while reducing development cycle time by 75%.
- Instituted .NET technology to manage projects throughout the project lifecycle. Facilitated resource optimization and tracked vendor milestone, resulting in a 30% increase in on-time project completion.
- Managed a cross-functional 4 member team in Phase II deployment of the Assessment System for National Council of Accreditation for Teacher (NCATE) accreditation.
- Performed process mapping to provide a blueprint of procedures that maintained data standards.