---
title: 008
description: A consultant with The FDA Group.
---

[The FDA Group's Consultant Finder ](https://www.thefdagroup.com/find-consultants)

# [008](https://www.thefdagroup.com/find-consultants/008)

 Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Mar 10, 2022 4:20:57 PM

**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

[View full post](https://www.thefdagroup.com/find-consultants/008)

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