Key Areas of Expertise
- Clinical Trial Operations and Inspection Readiness
- Regulatory Submissions and Compliance (eTMF, eISF)
- Business Process Improvement and Digital Transformation
- Data Integrity and Risk Management
- Document Management Systems and Digital Credentialing
- Stakeholder Engagement and Training
Professional Experience
Principal Consultant – BAFallen Consulting, LLC
Blue Bell, PA | Sept 2014-Present
- Provides strategic consulting to pharmaceutical and biotech companies, vendors, and CROs on clinical and regulatory process improvement and technology utilization.
- Supports clients in optimizing document management, regulatory submissions, and quality systems, ensuring compliance with GCP, FDA, and ICH standards.
- Leads assessments and implementations of electronic Investigator Site Files (eISF), enhancing inspection readiness and data accessibility for clinical trial sites.
- Advises on digital credentialing, offering expertise in secure document handling and site inspection processes, and facilitates process innovations across clinical operations.
Director, Global Clinical Trial Operations – Merck & Co., Inc.
Rahway, NJ | 2012-2014
- Managed an 11-member team and two functional outsourced partners, overseeing regulatory compliance, quality assurance, and vendor performance for clinical trial operations.
- Contributed to Merck's RFP process for regulated content management systems and led process improvement initiatives across clinical and regulatory operations.
- Developed SOPs and quality management practices for clinical documentation, ensuring timely and compliant trial execution.
Regulatory Specialist, Global Regulatory Operations – Merck & Co., Inc.
Rahway, NJ | 2010-2012
- Coordinated end-to-end regulatory submissions and served as the regulatory liaison for agency meetings.
- Piloted SAFE-BioPharma credentialing for clinical site staff and represented Merck in external initiatives, including the Clinical Research Information Exchange (CRIX) NCI initiative.
Project Lead, MRL IT Application Services – Merck & Co., Inc.
Rahway, NJ | 2009-2010
- Developed strategies for healthcare IT integration and managed a comprehensive assessment of Merck’s participation in healthcare IT landscapes.
- Led project management efforts for clinical systems and applications, ensuring alignment with regulatory and operational goals.
Manager, Worldwide Regulatory Coordination – Merck & Co., Inc.
Rahway, NJ | 1993-2009
- Coordinated global regulatory submissions, managing a team responsible for document management, data integrity, and regulatory compliance.
- Led process standardization efforts, contributing to Merck’s adoption of CDISC standards for clinical data and driving efficiency in clinical documentation.
Senior Data Coordinator, Merck Research Laboratories – Merck & Co., Inc.
Rahway, NJ | 1989-1993
- Led data management initiatives to support global marketing applications, developing standardized processes for clinical data collection and regulatory submissions.
- Pioneered remote data entry and data standardization techniques, contributing to Merck’s innovations in data management.
Education
Bachelor of Science in Biology
Pennsylvania State University, State College, PA
Associate Degree in Nursing
Montgomery County Community College, Blue Bell, PA
Professional Development
- Six Sigma Green Belt Certification
- Project Management Mini Camp
- Leader Effectiveness Training
- Change Execution Management
Publications and Presentations
- “Site Documentation: On the Record” – International Clinical Trials, August 2015
- PhlexEisf: Electronic Investigator Site File: Something for Everyone, Especially the Patients – Phlexglobal White Paper, March 2015
- eTMF + IRB Integration = Efficiency – TransPerfect Life Sciences White Paper, August 2016
- FDA Draft Guidance on Electronic Records and Signatures: The Next Chapter – Clinical Leader, October 26, 2017
- Data Integrity in Clinical Trials: 4 Key Concerns of The FDA & MHRA – Clinical Leader, November 2018
Presentations and Webinars
- DIA Annual Meetings (2004-2018): Speaker and track chair on topics including eTMF, eISF, inspection readiness, and digital transformation.
- MAGI Conference, Exl Pharma TMF Summit, SCOPE Conference, and Partnership in Clinical Trials: Presented on best practices for digital credentialing, eConsent, and site inspection readiness.
Awards and Recognitions
- MCC Champion Award for contributions to improving clinical trial efficiency and quality
- Special Recognition from Merck for leading SAFE-BioPharma credentialing initiative