Amber Solliday
East Greenville
Summary
With over 25 years of experience in the life science industries, I bring expansive clinical supply skills and knowledge to the table. As an effective business systems analyst, I specialize in understanding business processes, requirements, system functionality, data integrity, and regulatory compliance. In my role as an accomplished business process manager, I excel at identifying process gaps, proposing creative solutions, and leading change initiatives across cross-functional areas. Additionally, I have a proven track record as a clinical supply specialist, with expertise in supply strategy, documentation, and inventory management. With my strong project management skills, I have successfully overseen the procurement and management of clinical ancillary supplies for global clinical trials.
Overview
22
22
years of professional experience
Work History
Senior Project Manager, Clinical Operations
Ancillare LLC
06.2024 - Current
- Manage complex ancillary supply chain services for assigned global clinical trials
- Interface directly with management, quality assurance and supply chain teams to facilitate all clinical supply operations and processes while following Ancillare SOP’s
- Serve as a liaison and manage relationships between the organization and sponsor to share all relevant information including recommendations, requirements and progress of project
- Collaborate with internal and external stakeholders to implement a process for packaging convenience kits
- Create label proof for the finished kit with a GTIN (Global Trade Item Number) and all relevant details to align with regulatory requirements in the US and EU.
Project Manager, Clinical Supply
Ancillare LLC
01.2021 - 06.2024
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Per the study protocol requirements, manage ancillary supplies and equipment to support the study needs and clinical sites participating in global clinical trials
- Identified project risks to proactively mitigate potential setbacks.
- Managed change requests to ensure alignment with project goals and timelines.
Business Systems Analyst III, Clinical Services
Signant Health
06.2017 - 05.2020
- Facilitated sessions with cross functional teams and stakeholders to gather key business requirements to analyze and translate into functional and/or user requirements for complex applications and system integrations
- Elicited global process harmonization by utilizing use cases and workflow diagram analysis
- Provided system demonstrations and training to cross functional users in use of SmartSupplies software applications for PMD (Planning, Manufacturing, Distribution), LRA (Label Routing & Approval), LDP (Label Design & Print), EBR (Electronic Batch Records) and WMS (Warehouse Management System)
- Key contributor in developing automated system configuration templates for 5 SmartSupplies applications
- Ensured compliance throughout the SDLC and demonstrated best practices in all project activities, validation processes and documentation
Project Manager, Clinical Services
ClinApps
01.2016 - 06.2017
- Managed project plans for assigned workstreams to ensure project milestones and key deliverables were on target and timelines were met
- Authored User Requirement Specifications (URS) document compiled to include core requirements for multiple SmartSupplies system applications
- Facilitated meetings with designated Subject Matter Experts and successfully implemented 10 custom reports developed to fulfill specific business needs
- Supported customer FMEA (Failure Mode and Effects Analysis) workshop with cross functional project team to perform a detailed risk analysis on requirements outlined in the URS
Business Process Manager, Clinical Supply Technologies
Shire Human Genetic Therapies Inc.
10.2011 - 12.2015
- Key contributor for SDLC projects and successful system implementations for initial deployment and version upgrades for clinical software applications and integrations
- Managed and coordinated enhancements for system interfaces with Interactive Response Technology and Clinical Supply Distribution vendors to ensure development and testing standards were compliant with Shire expectations
- Successfully implemented a new process for approving configuration change requests for clinical supply software applications and revised Change Control SOP
- Successfully implemented a process to streamline the validation effort for Reports by consolidating tasks and documentation
- Created support documentation for the user community to leverage for system guidance, providing the ability to resolve questions
- Provided support to end users with troubleshooting and resolving system issues
Senior Clinical Supply Specialist, Pharmaceutical Sciences
Shire Human Genetic Therapies Inc.
05.2009 - 10.2011
- Managed clinical supply inventory and logistic activities for multiple on-going clinical trials, including depot transfers, site shipments and drug returns
- Collaborated with internal and external customers to develop and implement drug supply strategy plan
- Managed Clinical Supplies Documentation systems and content ensuring inclusion of essential documentation
- Coordinate pre-audit/inspection review
- Prepared clinical supply documentation required for the TMF (Trial Master File)
Clinical Supply Specialist, Pharmaceutical Sciences
Shire Human Genetic Therapies Inc.
12.2006 - 05.2009
- Develop clinical supply distribution and return plans with Clinical Supply project manager and contract provider(s)
- Facilitate the transfer and reconciliation of returned clinical supply drug from investigational sites
- Manage clinical supply inventory for projects assigned by interacting with vendors to ensure inventory records were up to date
Materials Supervisor
Acculogix, LLC
06.2003 - 12.2006
- Overseeing daily operation of the clinical materials warehouse (36,000 sq Ft.)
- Supervised and directed employees across multiple workstreams in fast paced environment, including receiving, inspection, staging materials for packaging operations, inventory control, shipping and distribution
- Assist in developing and validating internal electronic system to maintain Clinical Trial Data, including writing and executing user acceptance test scripts
- Developed procedures with Information Technology team for Clinical Trial Materials System to ensure processes are clearly defined and records and documentation are maintained
Education
Montgomery County Community College
Pottstown, PA01-2005
Skills
- Working knowledge of GxP, Title 21 CFR Parts 10/11, Annex 11/13
- Project Management
- Cross-Functional Collaboration
- Risk Assessment and Mitigation
- Change Management
- Process Improvement
- SDLC Guidelines & Documentation
- Functional and Technical User Requirements
- Interface Integrations
- Inventory and Logistics Management
Training Certifications
- Computer and Software Validation, 4/01/2015 / IVT (Institute of Validation Technology)
- SharePoint 2010, 7/01/2013 / Site Administration Training
- Validation of Computer Systems, 9/01/2012 / CfPIE- Center for Professional Innovation & Education
- Preparation, Packaging and Labeling of Clinical Trial Materials, 6/01/2007 / CfPA- Center for Professional Advancement
Timeline
Senior Project Manager, Clinical Operations
Ancillare LLC
06.2024 - Current
Project Manager, Clinical Supply
Ancillare LLC
01.2021 - 06.2024
Business Systems Analyst III, Clinical Services
Signant Health
06.2017 - 05.2020
Project Manager, Clinical Services
ClinApps
01.2016 - 06.2017
Business Process Manager, Clinical Supply Technologies
Shire Human Genetic Therapies Inc.
10.2011 - 12.2015
Senior Clinical Supply Specialist, Pharmaceutical Sciences
Shire Human Genetic Therapies Inc.
05.2009 - 10.2011
Clinical Supply Specialist, Pharmaceutical Sciences
Shire Human Genetic Therapies Inc.
12.2006 - 05.2009
Materials Supervisor
Acculogix, LLC
06.2003 - 12.2006
Montgomery County Community College
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