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About Just In Time GCP
As industry thought leaders, we bring an innovative approach to developing processes that support compliance and ensure a high quality TMF.
Why Choose Us?
We help your organization achieve operational excellence.
With over 100 years of combined experience in clinical research operations, our Leadership team can assist your organization in developing processes that are regulatory compliant, yet consistent with the resourcing capabilities of your organization. We understand the complexities of small and mid size companies where resources are limited and timelines are critical.
Through our strong focus on regulatory inspection readiness, we also provide a wide range of services that help organizations achieve operational excellence and regulatory compliance. Our approach to TMF management is based on compliance, not a checklist of required records. We implement processes that meet your organizational resourcing strategy. Our TMF management team is available to support resourcing of TMF management. Whether your needs are temporary or long term, Just in Time GCP is your solution for compliant TMFs100
Quality Management Systems
A Quality Management System is the cornerstone of a clinical drug development program. Just in Time GCP is the solution to all of your quality systems needs.
TMF Management
We help your organization harness the power of an eTMF to drive quality and ensure inspection readiness. We offer strategies for implementing a successful eTMF system.
Regulatory Inspection Readiness
We have extensive experience in preparing organizations for regulatory inspections. We assist our clients in preparing for the inspection, managing the inspection, and responding to regulatory findings.
Who We Are
Our Leadership Team
Donna Dorozinsky
President & CEO, Just in Time GCP
As the President & CEO of Just in Time GCP, Donna is responsible for running all facets of the business. She is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experiences dealing with small to large Pharma and biotech companies, academic centers, regulatory agencies, CROs, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance. She is a member of the TMF Reference Model Steering Committee, a member of Association of Women Entrepreneurs, and honored to be a Founding member of Society of Nurse Scientists, Innovators Entrepreneurs, & Leaders. Donna serves on the Board of Trustees at Gwynedd Mercy University where she received her BSN and also has an MSN from Widener University. Donna is a frequent presenter at conferences and workshops speaking on topics related to Clinical Compliance, Inspection Readiness, and TMF management.
Jamie O'Keefe
Vice President, Business & Technology Consulting
As Vice President, Business & Technology Consulting, Jamie is responsible for providing strategic leadership to consulting services offerings for Just in Time GCP clients. Jamie has over 20 years of business consulting and technology implementation experience. He has focused on Clinical and Regulatory consulting for the past 15 years, having implemented large scale process and technology transformations for both top tier pharma and CROs and emerging biotechs. Jamie has supported programs to implement harmonized business processes and systems across Trial Master Files, Clinical Trial Operations, Clinical Site Monitoring, Risk Based Quality Management, Clinical Data Management and Regulatory Information Management. Jamie has long standing experience with the leading R&D technology vendors, such as Veeva, Medidata, Opentext, Oracle and WCG.GCP
Marion Mays
Vice President, Inspection Readiness
As the Vice President of Inspection Readiness, Marion is responsible for providing strategic leadership to our Services Division focusing on TMF management and Inspection Readiness. Marion is a dynamic inspirational leader in the Life Sciences space with over 30 years of experience. Offering a unique combination of both strategic and operational abilities combined with creative thinking. She is an advocate for quality through essential information management practices; competent training for all contributors and consumers of the documentation which supports the advancement of clinical outcomes. Highly skilled in developing and implementing enterprise-wide programs and technical systems in regulated environments. A proven track-record in designing, building, and leading cross-functional teams across multiple disciplines. In-depth experience with quality and compliance processes in the pharmaceutical industry with focus on supporting organizations through GCP regulatory inspections with FDA, MHRA, EMA, and PMDA. Her experience in R&D, Clinical Research, Manufacturing, Quality Assurance, Records & Information Management, Quality Control, Operations, System Implementations, and Regulatory Inspections, brings tremendous experience and knowledge to our clients.
Jennifer Stamper
Director, TMF Services
As the Director of TMF Services and Business Operations, Jenn is responsible for the management of Services group members focusing on inspection readiness. Jenn has a passion for leading people and fostering their career growth within the industry. She started her career in clinical research at a large CRO where her career grew to lead a department of 150+ employees, supporting over 750 active projects with paper and electronic TMFs through migration, set-up, maintenance, quality and delivery of the Trial Master File. Over the past five years, Jenn has supported clients in N.A., EPA, and APAC through EMA, MHRA and FDA inspections. She is actively involved with the TMF Reference Model Working Groups, attends industry conferences and has presented on panels at eXL events. Serving as a member of the leadership team with Just in Time GCP, Jenn’s focus is on the continued growth and development of our company, inspection readiness strategy and supports new business through marketing activities and fostering partnerships.
