Clinical & Regulatory Operations Process Specialist


Recognized Leader with Six Sigma Green Belt & extensive experience problem-solving; offering innovative business process improvement and technical guidance; broad knowledge of applications, regulated document repositories and systems.



Independent consultant providing innovative guidance on clinical & regulatory process business enablers and technology.


  • I support Pharma and biotech companies, vendors, and partners to innovate and improve their process and use of technology by advising and providing services including document audit and management.

MERCK & CO., INC.        AUG. 1989 – SEPT 2014

Leading Pharma Company where I developed my expertise, leadership and inter-personal skills

Director, Global Clinical Trial Operations


Regulatory Specialist, Global Regulatory Operations


Project Lead Application Services, MRL IT


Manager, Worldwide Regulatory Coordination


Senior Data Coordinator, Merck Research Laboratories


Director, GCTO – Managed 11 member team and 2 functionally outsourced partners and vendor partners; Contributed expertise on RFP team for regulated content management system; ensured oversight, compliance and quality;

Regulatory Specialist/ Manager – Coordinated end to end regulatory submissions; supported regulator meetings; granted many awards and earned Six Sigma Green Belt; represented Merck on many external technical initiatives including leading Merck’s pilot testing of SAFE-BioPharma credentialing of Clinical Site Staff and as a member of the Clinical Research Information Exchange (CRIX) NCI initiative.

Project Lead, IT – Developed external healthcare IT strategy and oversight of managing processes, projects and people; performed comprehensive landscape assessment of Merck participation

Senior Data Coordinator - Led data management team which processed clinical data to support global marketing application filings; initiated the standardization and documentation of processes leading to the adoption of CDISC; led team to coordinate end to end process of data collection from clinical site to regulatory release and pioneering the remote data entry concept


BS, Biology, Pennsylvania State University, State College, PA

AD, Nursing, Montgomery County Community College


GCP Training

Leader Effectiveness Training        Change Execution Management

Project Management Mini Camp        Six Sigma Green Belt Training and Certification


2004-15 DIA Meeting Roles (Planning, Chairing, Speaker): Annual US EDM and ERS/eCTD and EU EDM; Speaker at MAGI Conference; Global Innovation Leaders’ Summit; Partnership in Clinical Trials (Spain), BIO-IT presentation on digital credentialing for security

2015: Webinar Phlexglobal: eISF: The Key to Site Inspection Readiness and How to Enable Anywhere, Any Data Access Without Compromising Security; Webinar: eTMF Challenges, Opportunities and Trends

2016: Exl Pharma Speaker TMF Summit & Inspection Readiness; SCOPE Conference (Speaker/Track Chair), DIA Annual, Regulatory Submissions Information Document Management and EU EDM (Planning Committee/Speaker); Clinical Technologies (Speaker), Exl Pharma ISF Conference (Co-Chair/Speaker); MAGI: Speaker

2016: Webinar: TransPerfect/Schulman IRB: "eTMF + IRB Integration = Efficiency”

MCC Champion - a special honor bestowed upon individuals who made significant contributions to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials

2017-18: Exl Pharma TMF & Inspection Readiness Speaker on Digital & Electronic credentials; DIA RSIDM & Annual Meeting Contributor         Webinar: Steps to Paperless Clinical Trials: Creating Certified Copies and More: Complion

2019: Exl Pharma CROWN (SOPs: They must be Compliant, BUT do they have to be Painful?); DIA RSIDM (eConsent: Permission to Adopt) and Co-Instructor (Regulatory Content and Submissions: Authoring through Archive) ; ACRP (Applying Six-Sigma Tools and Concepts to Your Clinical Research Activities)


Fallen, B.A. (2015) “Site Documentation: On the Record” International Clinical Trials, August 2015: 48-50

White Paper: Betsy Fallen. “PhlexEisf: Electronic Investigator Site File: Something for Everyone, Especially the Patients” March 2015.

White Paper: B. Fallen and M. Smyth: eTMF + IRB Integration = Efficiency: TransPerfect Life Sciences, August 2016

White Paper: Betsy Fallen and Rick Arlow: FIRST STEPS TO PAPERLESS CLINICAL TRIALS:  CREATING CERTIFIED COPIES & MORE; Complion Feature Article July 2017

Fallen, Betsy (October 26, 2017) FDA Draft Guidance on Electronic Records and Signatures: The Next Chapter, Clinical Leader Guest Column

Fallen, Betsy; MAGI Vol. 14, No. 7, July 2018: It’s About Time We Get Serious about eConsent

Fallen, Betsy; (November 2018); Data Integrity in Clinical Trials: 4 Key Concerns Of The FDA & MHRA; Clinical Leader Guest Column 

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