Princeton Junction, New Jersey, United States
Clinical Operations leader specializing in Trial Master File (TMF) strategy, inspection readiness, and global process optimization within biopharmaceutical environments. Brings 15+ years of leadership experience driving end-to-end TMF governance, system enhancements (Veeva eTMF), and regulatory compliance across large-scale, multi-study portfolios. Proven track record of leading TMF transformation initiatives, including post-M&A integrations (>200 studies), inspection preparedness, remediation, and archival strategy, consistently achieving successful Health Authority outcomes with no critical findings. Recognized for building scalable TMF frameworks, advancing automation, and delivering measurable cost savings while strengthening inspection readiness. Trusted cross-functional leader partnering with Clinical Operations, QA, Regulatory, and external partners to align global documentation standards, improve operational performance, and reduce regulatory risk.
Offering expertise in clinical & regulatory operations, clinical trial documentation, Trial Master File (TMF) inspection readiness, remediation, integration, migration, mergers and acquisitions (M&A).
Global Process Lead, TMF Archival and leader of global teams that ensure planning, development, and delivery of high-quality clinical documents. Strong business background in electronic document management systems (Documentum, Livelink, Veeva Vault), document control and trial master file (TMF) processes and strategies. Successfully established strategic partnerships with CROs and vendors and engaged with external partners on operations, performance, quality, cost, governance, and issue resolution. Successfully planned and transitioned clinical trial documentation and TMF to and from BMS in support of Mergers & Acquisition (M&A) projects and In-Licensing / Out-Licensing activities.
TMF Global Process Lead responsible for establishing eTMF (Veeva Vault) archival and processes at BMS. Identified resources and aligned at the team level to drive improvement activities, and leading optimization activities to align with the Good Clinical Practices (GCP). Served as the key point of contact for the assigned global process and local sub-processes including integration of TMF from acquisitions and TMF oversight and remediation of outsourced studies.
Clinical Business System Lead for the eTMF systems (Livelink 4 Clinical), responsible for managing the Essential Document Management (EDM) team including all individuals involved in receiving, scanning, reviewing, filing, archiving, and retrieving essential documents. Responsible to work with cross-functional TMF Community of Practice on operational standards and processes related to TMF such as quality goals, oversight methods, good document management practice, archiving operating model and managed manage approach to TMF Plans and Indexes. Supported inspections (EMA, FDA, MHRA, Swiss Medic) and internal audits with no critical findings for TMF and closed CAPAs.
Offering expertise in clinical operations, clinical trial documentation, Trial Master File (TMF) inspection readiness, remediation, integration, migration, mergers and acquisitions (M&A).