Amy Rupp
Riverview,FL
Summary
Results-driven professional with extensive experience in leadership and strategic oversight. Adept at driving organizational success through effective team collaboration and dynamic problem-solving. Recognized for adaptability and keen focus on achieving objectives.
Overview
27
27
years of professional experience
Work History
Associate Director, Adaptive Clinical Trial Technology
CSL BEHRING
02.2024 - 02.2025
- Skills acquired: Program Management, Technical Strategy, Regulatory Submissions, Continuous Improvement, Innovation, Stakeholder Engagement, Feasibility Assessment
- Responsibilities:
- Portfolio level ACTT solution planning and for providing a framework for Program/Study level innovation that ensures robust data quality and compliance with regulatory requirements including regulatory submissions
- Ensure implementation of adaptive clinical trial technology enhances user experience (site/patient) and is cost elective, meeting budget targets aligned with competitive industry practices
- Manage feasibility assessment and guidance to program and study teams (insourced and outsourced)
- Expertise for assessing external service providers, technologies, and the use of the functionality for each technology
- Support qualification and implementation of technical strategy for eCOA, IRT, eConsent, medical devices/wearables and technical support related to cardiac safety, respiratory, and imaging
- Pilot innovation projects in collaboration with relevant stakeholders
- Create and maintain Communication Framework (stakeholder engagement) for information sharing/training, and feedback for continuous improvement with stakeholders on Program and Study level
- Drive standardization of documents, templates, licenses, training, and processes
- Supervise staff and provide support for their development, training, and day-to-day work
- 1 years, 1 months
Associate Director, Interactive Response Technology
CSL BEHRING
03.2017 - 02.2024
- Skills acquired: Clinical Development, Protocol Development, Implementation Strategy, Performance Management, Compliance, Relationship Management, Data Standardization, Inspection Readiness, CRO Oversight
- Responsibilities:
- Direct and manage technical project team in implementation and maintenance of study specific IRT systems
- Oversee resource allocation and adjust based on project scope, budget, and timeline
- Ensure personnel complete work to the highest quality standards while maintaining data quality and compliance
- Provide training, mentoring, and performance management
- Manage and oversee IRT and eConsent strategy, processes, and systems
- Adapt operating model based on changes to clinical development, clinical trial supply processes and systems, and industry trends
- Provide advice and direction to teams utilizing technology solutions
- Collaborate on content and author content for clinical study outline and clinical study protocol
- Lead selection, relationship management, metrics, and governance activities for external service providers including CROs
- Define and implement data standards with regards to terminology, functionality and reporting and ensure that these standards are, as far as is practicable, applied to all studies, regardless of the vendor selected
- Oversight of departmental budget, contracts, and invoicing
- Ensure inspection readiness
- 7 years, 0 months
Sr Manager, RTSM Lead
BIOCLINICA
10.2011 - 03.2017
- Skills acquired: Systems Implementation, Issue Resolution, Business Specification Requirements, Employee Training, Business Development, Sales Pipeline, Technical Support, Resource Allocation
- Responsibilities:
- Manage staff located both in office and home based throughout the US, Europe and India
- Review and provide input on sales pipeline, monthly forecast, master service agreements, contracts, change orders and customer billing
- Manage oversight for cross departmental timelines, deliverables, and issue resolution
- Support Business Development in capabilities meetings, bid defenses, general customer presentations and at conferences
- Review and approve requests for information, cost proposals (RFP), contracts and master service agreements
- Ensure product and departmental quality
- Provide representation in onsite customer audits
- Create and maintain comprehensive RTSM employee training program
- Establish and oversee Subject Matter Expert program
- Assist staff in customer communications and escalation resolution
- Representation during customer governance committees
- Operational representation on IRT product and defect resolution committees
- Consult on feature enhancements and defect triage of IRT product
- Review and approve core product system technical business requirements
- Review and approve customer specific implementation requirements
- 5 years, 6 months
Manager, Process Improvement
CENDUIT
08.2010 - 10.2011
- 1 years, 3 months
Manager, Project Management Office
UNITED BIOSOURCE CORPORATION
06.2008 - 07.2010
- 2 years, 2 months
Label Operations Manager
BILCARE, INC
02.2006 - 06.2008
- 2 years, 5 months
IRT Technical Services, Team Leader
FISHER CLINICAL SERVICES, INC
03.1998 - 02.2006
- 8 years, 0 months
Education
High School Diploma -
Parkland High School
Allentown, PASkills
- Project management
- Strategic leadership
- Analytical thinking
- Coaching and mentoring
- Decision-making
- Team collaboration and leadership
- Process improvement
- Key relationship management
- Operations management
- Technical implementation
- Crisis management
- Onboarding and training
- Organizational development
- Budget management
Timeline
Associate Director, Adaptive Clinical Trial Technology
CSL BEHRING
02.2024 - 02.2025
Associate Director, Interactive Response Technology
CSL BEHRING
03.2017 - 02.2024
Sr Manager, RTSM Lead
BIOCLINICA
10.2011 - 03.2017
Manager, Process Improvement
CENDUIT
08.2010 - 10.2011
Manager, Project Management Office
UNITED BIOSOURCE CORPORATION
06.2008 - 07.2010
Label Operations Manager
BILCARE, INC
02.2006 - 06.2008
IRT Technical Services, Team Leader
FISHER CLINICAL SERVICES, INC
03.1998 - 02.2006
High School Diploma -
Parkland High School
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