Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Tam LaFleur

Saint Augustine,FL

Summary

Dynamic, result driven and dedicated leader with extensive experience in Operational Excellence, Clinical Research, Clinical Operations, Regulatory Compliance and Quality Management. Particularly adept at managing complex global programs. Reputation for analytical problem solving and for being creative, strategic, effective leader skilled at gaining mutual respect and trust.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Sr Business Process Improvement Manager

Medtronic Inc
01.2015 - Current
  • Lead team of team of four supporting global program management specializing in process development and optimization
  • Clinical Operational Excellence Program Leadership
  • Develop, facilitate and maintain Strategic Planning for Clinical, Quality and Regulatory partners
  • Develop and facilitate Risk Based Planning leading to accelerated timelines
  • Lead Value Stream Mapping (VSM) initiatives within Clinical and adjacent functions
  • Assessed, developed, and implemented project/program management and reporting tools increasing program visibility through automated metric and KPI reporting.

EU MDR Clinical Program Lead

Medtronic Inc
  • Implemented an operational oversight committee to sustain the harmonized processes leading to $2M in efficiencies from tool consolidation to reduction of operating unit level process audits
  • Successfully advocated for regulatory guidance change resulting in cost avoidance of $15M
  • Recipient of Clinical Research Excellence award 2021
  • Led the Medtronic global Clinical team in development and implementation of harmonized Clinical Evaluation processes – leading to $6M savings in operating unit redundancies
  • Recipient of Clinical Research Excellence Award, 2018.

Medtronic/ Covidien Integration Project – Clinical Systems Lead

Medtronic Inc
  • Led Clinical systems integration program during the Medtronic/Covidien integration and reducing redundant systems leading to $5M in savings.

Clinical Project Manager

Covidien
11.2008 - 06.2014
  • Responsible for the following day-to-day activities for multi-phase, multi-center, US and Global clinical trials for various product lines in the Surgical Solutions global business unit
  • Develop clinical protocols, informed consent and assist with CRF design
  • Identify, select and manage clinical sites and CROs
  • Establish CABs, CECs and DSMBs as required to support different levels of clinical trials
  • Drives the communication/publication plans for the endomechanical and soft tissue franchises
  • Lead medical affairs strategies to support the Product Development Process
  • Oversee the clinical study budget forecasting and maintenance and key clinical study deliverables
  • Assist with pre-clinical strategy to support product development
  • Liaise with Regulatory Affairs, Marketing, Quality and other cross-functional business partners to support development and commercial products
  • Serves as the Clinical Systems expert for Global Clinical Affairs Group (CTMS, RDC and eTMF systems)
  • Develop and implements study metrics to standardize objective measurement of site, team and project performance
  • Evaluated, selected and implemented eTMF system for the Surgical Solutions Clinical Affairs Group.

Education

BS - Biology -

University of Connecticut
Storrs, CT
01.2008

Skills

  • Optimizing Workflows
  • Key Performance Indicators, Trend Analysis
  • Business Process Mapping
  • Risk Assessment
  • Staff Development
  • Strategic Planning
  • Operations Management
  • Continuous Process Improvement
  • Business process optimization
  • Electronic Data Capture (EDC – Oracle, Medidata, Acumen)
    Clinical Trials Management System (Siebel Clinical), eTMF (NextDocs) clinical data management and monitoring
    Clinical Literature, Clinical Appraisal Tools (ReadCube, Distiller, Curator)
    Clinical registries – clinicaltrialsgov
    Word, Excel, PowerPoint, Visio, Project, SharePoint, MindMap,
  • Business process oversight

Certification

  • Lean Sigma Green Belt, Covidien - 2014

Languages

English
Native or Bilingual
Vietnamese
Native or Bilingual
French
Limited Working
Spanish
Limited Working

Timeline

Sr Business Process Improvement Manager

Medtronic Inc
01.2015 - Current

Clinical Project Manager

Covidien
11.2008 - 06.2014

EU MDR Clinical Program Lead

Medtronic Inc

Medtronic/ Covidien Integration Project – Clinical Systems Lead

Medtronic Inc

BS - Biology -

University of Connecticut

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Tam LaFleur