Kristen F. LeBlanc
Overview
23
23
years of professional experience
Work History
Senior Manager, Clinical Development
AbbVie/Soliton, Inc.
01.2021 - Current
- Lead planning and execution of studies keeping within budget, scope, and schedule
- Lead study start up activities including site contracts and budgets
- Lead all clinical operations including site qualification, initiation, monitoring, and closeout activities
- Lead interactions with IRB including developing budgets, and submission and close out actions
- Write clinical research protocols, informed consent documents, and clinical report forms
- Represent company externally to investigators and trial site administrators
- Manage numerous vendors including for multiple studies simultaneously
- Support submissions and responses to regulatory bodies
- Demonstrate strong organizational and problem-solving abilities in addressing and rectifying operational issues
- Remain current in the latest standards of clinical study conduct
- Support due diligence activities prior to company acquisition
Clinical Project Manager
Cytrellis Biosystems, Inc.
01.2018 - 01.2021
- Manage clinical operations including site initiation, monitoring, and site closeout activities
- Manage IRB submissions, continuing reviews, and study closures
- Write clinical research protocols, informed consent documents, and clinical report forms
- Analyze and present data and draft reports of clinical results
- Support clinical staff in the treatment rooms during procedures
- Cultivate excellent relationships with vendors: Canfield Scientific Inc, statisticians, independent review panel, and medical writers
- Assist in development of Clinical SOPS to ensure compliance with operational standards and procedures
Quality Engineer – CAPA Facilitator
Philips, Inc.
01.2017 - 01.2018
- Managed activities and workflow within the CAPA process for Philips business units
- Demonstrated effectiveness in task completion, decision-making, empowerment of others, time management, training, problem solving and team leadership
- Lead CAPA process improvement initiatives and implement according to scheduled timelines
- Facilitated weekly CAPA Board meetings
Senior Quality Assurance Specialist
Cynosure, Inc.
01.2015 - 01.2017
- Managed Quality Assurance Specialists and Device History Record Specialist
- Provide guidance and mentoring to lower-level personnel in setting work priorities and accomplishing daily tasks
- Managed CAPA system for two facilities
- Lead CAPA Board meetings with senior management
- Managed Internal Audit program for two facilities
- Ensure the compliance of the internal departments to applicable regulations
- Managed Quality Assurance Training Program
- Assisted the development and administer special projects such as FDA/MDSAP readiness plans, training programs, and integration of quality systems
Quality Assurance Specialist
Cynosure, Inc.
01.2014 - 01.2015
- Coordinated CAPA Program
- Maintained Quality Assurance Training Program
- Maintained complaint system and assists in investigations
- Assisted in the internal audit program to help ensure the compliance of the internal departments to applicable regulations
- Aided in the tracking and trending of CAPAs, Product Complaints, Audits, and Employee Training through the use of various databases and statistical tools
- Reviewed production batch records, data forms, and other associated documentation
QA/RA Administrator
DENTSPLY IH Inc.
01.2012 - 01.2014
- Assisted with the management of the Quality and EHS System
- Worked cross functionally to ensure Quality System and EHS System was effectively implemented, and requirements, rules and regulations were adhered to
- Managed daily customer complaints and evaluated for appropriateness
- Examined root cause analysis and determined if further corrective action was necessary
- Held responsibility for Quality and EHS System document control
- Acted as the local document-control system administrator
- Assisted with internal audits, including creating audit reports and determining proper corrective and preventive actions
- Led cross functional team project for process improvement using tools such as 5S, Kaizen, lean methods, Six Sigma, etc
- Administered Quality, Regulatory and compliance training
- Updated and kept proper Quality and EHS system records, reports and statistics
Abutment Design Coordinator
DENSTPLY IH Inc. /Astra Tech Inc.
01.2009 - 01.2012
- Developed team to improve communication and response to customers’ and sales team’s issues/concerns, to ensure customer satisfaction in a timely manner
- Worked directly with Development and Customer Service to improve processes and customer satisfaction
- Received and processed Atlantis abutment complaints and remake the process
- Provided assistance to technicians and customers on more difficult and elevated issues
Customer Service/Technical Services Supervisor
Astra Tech Inc. / Atlantis Components, Inc.
01.2005 - 01.2009
- Supervised daily operational activities
- Provided dental technical assistance on product line to clinicians and laboratories
- Resolved customer issues/concerns in an expeditious manner with high customer satisfaction
- Created and administered training programs for employees and customers
- Participated in process improvement meetings with department managers
- Managed schedules
- Assisted in Sales/Marketing activities
- Managed consignments of product
- Assisted accounting department with daily activities
Clinical Manager/Inventory Manager/Dental Assistant
Devonshire Dental Associates
01.2002 - 01.2005
- Oversaw all clinical procedures within the office and assisted the doctor during all general dental procedures for adults
- Additional responsibilities included inventory control, temporary crowns, night guards, bleaching trays, overall maintenance of office, and OSHA and HIPAA compliance
Education
Masters of Business Administration -
University of Massachusetts
01.2018
Bachelor of Science - Business Administration
University of Massachusetts
01.2014
Associates of Science - Hospitality Management
University of Cape Breton
01.1990
Skills
- Business performance management
- Reporting oversight
- Resource allocation
- Industrial engineering
- Material accountability systems
- Logistics support services
Affiliations
- Society of Clinical Research Associates
- Association of Clinical Research Professionals
Accomplishments
- Clinical Project Management Certificate - Barnett International Inc.
- Clinical Research Associate 10 Week On-Boarding Program – Barnett International Inc.
- Clinical Research Auditing Certificate – Barnett International Inc.
- Good Clinical Practices – CITI - Exp 2025
- Lean Six Sigma Green Belt Certification
- Quality 101 - ASQ Certification
- 30-Hour Occupational Safety and Health Training Course
- Radiology Certificate - Tufts University
Timeline
Senior Manager, Clinical Development
AbbVie/Soliton, Inc.
01.2021 - Current
Clinical Project Manager
Cytrellis Biosystems, Inc.
01.2018 - 01.2021
Quality Engineer – CAPA Facilitator
Philips, Inc.
01.2017 - 01.2018
Senior Quality Assurance Specialist
Cynosure, Inc.
01.2015 - 01.2017
Quality Assurance Specialist
Cynosure, Inc.
01.2014 - 01.2015
QA/RA Administrator
DENTSPLY IH Inc.
01.2012 - 01.2014
Abutment Design Coordinator
DENSTPLY IH Inc. /Astra Tech Inc.
01.2009 - 01.2012
Customer Service/Technical Services Supervisor
Astra Tech Inc. / Atlantis Components, Inc.
01.2005 - 01.2009
Clinical Manager/Inventory Manager/Dental Assistant
Devonshire Dental Associates
01.2002 - 01.2005
Masters of Business Administration -
University of Massachusetts
Bachelor of Science - Business Administration
University of Massachusetts
Associates of Science - Hospitality Management
University of Cape Breton