Jennifer Bedard
Summary
Over 17 years of clinical research experience including study start-up/site activation, site monitoring, regulatory submissions and project management. Providing support, coordination, and leadership for studies that involve NHI sponsored, Investigator-initiated, and industry sponsored Phase I, II, II and IV clinical trials.
Overview
31
31
years of professional experience
1
1
Certification
Work History
Global Regulatory and Start-Up Manager
IQVIA
02.2024 - Current
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines
- Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required
- Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required
- Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents
- Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable)
- Mentor and coach colleagues as required
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information
- May take a lead role in developing long standing relationships with preferred IQVIA customers
- Deliver presentations/trainings to clients, colleagues and professional bodies
Global Site Activation Manager
ICON, plc
11.2021 - 02.2024
- Oversees day to day global management of all aspects of site activation in the projects assigned
- Support and/or participate in pre-award/bid defense activities
- Oversee the execution of Start Up (including pre-award through Site Activation) and/or Lifecycle Maintenance for assigned projects in accordance with the agreed start up strategy and adhering to agreed project timelines
- Manage Regional Start-Up Leads, Site Activation Specialists, Contract Associates and Local Regulatory Associates
- Attend client calls and present Start-Up activities
- Develop, implement and maintain the Site Activation Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required
- Collaborate with key stakeholders both internal and external, through effective communication and resolution management, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the Site Activation Management Plan
- Create essential document templates for study
- Work in collaboration with regulatory on strategy/expectations and parameters for submissions and all necessary authorizations
- Provide ongoing updates and reporting to various levels of the organization, both study team and in some cases senior level colleagues
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required
- Mentor and coach colleagues as required
- Deliver presentations/training to clients, colleagues and professional bodies, as required
- Oversee contract/budget timelines to ensure milestones and target dates are being met
- Utilize risks and mitigation strategies to overcome any potential delays that might impact project
Team Lead/Senior Clinical Research Coordinator
University of Kansas Medical Center
08.2020 - 11.2021
- Responsible for study start-up through closeout activities for all studies at all locations
- Manages other research nurse coordinators, coordinators, and research assistants
- Project management of studies of coordinators that I manage
- Responsible for training, evaluations, and mentoring of coordinators
- Escalate findings and action plans to appropriate parties using root cause analysis
- Oversees study timelines, clinical trial budgets, coordinates development of study plans, regulatory, CRF's, SOPs and other study reports
- Primary contact for sponsors
- Create, track and report project timelines
- Coordinate and ensure maintenance of Trial Master File
- Participate in investigator, site, and monitoring visits
- Development and maintenance of IRB, consent forms and source documents
- Conduct patient visits per the protocol
- Provides oversight and assists with internal monitoring
- Oversees multiple sites working on collaborative projects
- Responsible for budget allocation and approval of invoices
- Prepare and present project information at internal and external meetings
- Monitor all department trials for ensure compliance in all aspects
- Create, maintain, and QA databases for all research studies
Clinical Research Project Manager
University of Kansas Medical Center
01.2019 - 08.2020
- Responsible for study start-up through closeout activities for all studies at all locations
- Oversees study timelines, clinical trial budgets, coordinates development of study plans, regulatory, CRF's and other study reports
- Execute all aspects of trial per the contract from study initiation through close-out
- Primary contact for sponsors
- Create, track and report project timelines
- Escalate findings and action plans to appropriate parties
- Supervise assigned staff consisting of research assistants and coordinators
- Coordinate and ensure maintenance of Trial Master File
- Participate in investigator, site, and monitoring visits
- Development and maintenance of IRB, consent forms and source documents
- Conduct patient visits per the protocol
- On-site monitoring experience
- Oversees multiple sites working on collaborative projects
- Responsible for budget allocation and approval of invoices
- Prepare and present project information at internal and external meetings
- Train and coordinate work of project support staff
- Monitor all department trials for ensure compliance in all aspects
- Create, maintain, and QA databases for all research studies
Clinical Trials Coordinator II/Team Lead
Children’s Mercy Hospital
Kansas City, USA
05.2010 - 12.2018
- Ran study start-up activities for the Endocrine department
- Reduced study start-up time to 3 months
- Assigned studies to coordinators and mentor them on study coordination
- Responsible for recruitment and consenting for research study participants for all Endocrinology studies
- Project management all of department studies
- Responsible for scheduling and performing patient visits
- Coordinated procedures with other departments
- Responsible for data and sample collection and data entry
- Coordinated with lab regarding sample collections and shipments
- Participate in site and monitoring visits
- Development and maintenance of IRB documents
- Assisted in writing study protocols for investigator-initiated studies
- Trained and mentored new staff new staff
- Oversaw compliance and quality of studies as lead coordinator
- Created and maintained databases for all research studies
- Oversaw multiple sites working on collaborative projects
Research Coordinator
Cleveland Chiropractic College
Overland Park, USA
02.2006 - 04.2010
- Responsible for recruitment of research study participants
- Ran Evidence-Based Practice studies across the US involving over 150 chiropractic offices
- Attended health fairs and provided presentations at various organizations to promote awareness and recruitment
- Conducted pre-screening interviews and exams on potential participants
- In charge of all data collection
- Coded data for entry into databases
- Created and maintained databases for all research studies
- Helped collect patient vitals and perform patient visits
- Conducted tests and provided therapy treatment for eligible patients
- Conducted statistical analysis on the data to aid in the writing of research papers
- In charge of monitoring the budget for the Research Department
- Assigned work to other coordinators
Marketing Assistant
BounceBack, Inc.
Kansas City, USA
02.2005 - 02.2006
- Coordination of start-up process for new counties
- In charge of development of brochures for new clients
- Responsible for executing all marketing initiatives, (i.e., tradeshows, advertising, etc.)
- Create proposals and presentations to send to prospective clients
Resource and Training Manager
Verizon
Lowell, USA
08.2000 - 12.2003
- Responsible for 6 direct reports and 50 indirect reporting people
- Responsible for all reports for the Northeast District
- Set up and trained new and existing staff on programs used in Center
- Coordination of workforce schedules to ensure adequate staff available
- Responsible for facilitating company initiatives within the Center
- Responsible for working with inside and outside vendors to ensure daily operations
- Responsible for hearing and deciding grievances among union employees
- Monitored ACD for Center
Marketing Coordinator
Hay Management Consultants
Kansas City, USA
10.1995 - 06.2000
- Created proposals and presentations for clients and potential clients
- Responsible for development and implementation of all marketing events
- Designed marketing materials for office, as well as worked with Corporate Marketing Department to create materials
- Maintained client database
- Responsible for marketing communications to clients and prospects
Marketing Assistant
VITEC, Inc.
Overland Park, USA
01.1994 - 10.1995
- Created proposals and presentations for clients and potential clients
- Responsible for development and implementation of all marketing events
- Department to create materials
- Maintained client database
- Responsible for marketing communications to clients and prospects
Education
ACRP CCRC -
09.2024
Bachelor of Arts - Speech Communications
University of Maine
01.1993
Skills
- Advanced knowledge of multiple disease fields
- Strong understanding of process analysis and management
- Extensive study start-up experience
- Thorough regulatory knowledge of FDA, ICH, and GCP regulations and guidelines
- Strong training and managerial skills
- Extensive project development and management
- Excellent interpersonal and communication skills
- Complete work with high degree of proficiency and autonomy
- Substantial data management experience
Certification
ACRP CCRC, 07/20/11
Timeline
Global Regulatory and Start-Up Manager
IQVIA
02.2024 - Current
Global Site Activation Manager
ICON, plc
11.2021 - 02.2024
Team Lead/Senior Clinical Research Coordinator
University of Kansas Medical Center
08.2020 - 11.2021
Clinical Research Project Manager
University of Kansas Medical Center
01.2019 - 08.2020
Clinical Trials Coordinator II/Team Lead
Children’s Mercy Hospital
05.2010 - 12.2018
Research Coordinator
Cleveland Chiropractic College
02.2006 - 04.2010
Marketing Assistant
BounceBack, Inc.
02.2005 - 02.2006
Resource and Training Manager
Verizon
08.2000 - 12.2003
Marketing Coordinator
Hay Management Consultants
10.1995 - 06.2000
Marketing Assistant
VITEC, Inc.
01.1994 - 10.1995
ACRP CCRC -
Bachelor of Arts - Speech Communications
University of Maine