Summary
Overview
Work History
Education
Skills
Languages
Vendor Experience
Timeline
Generic

Jennifer Earle

Ottawa

Summary

Highly motivated team player with over 20 years of project, client, and site management experience. Capable of overseeing and implementing multiple responsibilities simultaneously, leading cross-functional teams to project success. Extensive international experience in Europe, Asia, and South America, demonstrating sensitivity to diverse cultural and business environments. Skilled in strategic planning, risk management, and client relations; known for adaptability, problem-solving, and fostering collaboration to achieve organizational objectives.

Overview

25
25
years of professional experience

Work History

Program Manager

ICON
01.2024 - Current
  • Manages project contractual deliverables. Proactively identifies risks and issues through ongoing review of project progress and metrics to ensure adherence to the contractual agreement for assigned programs/projects (time, quality/scope, and cost deliverables). Leads presentation of internal project status reviews, and is accountable for action item follow up. Develops in depth analysis and projections of project timelines and financials for senior leadership and customer management.
  • Acts as primary liaison with client. Understands and manages client contractual, organizational and relationship needs/expectations. Chairs and leads meetings, acts as lead contact for program-level matters and if assigned as primary project manager for complex studies, as the cross-functional study lead. Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan.
  • Leads and directs cross-functional team and third parties/vendors. Has a detailed understanding of each functional service area and is able to lead multifaceted functional teams effectively. Able to conceptualize and articulate dynamic operational strategies, then mobilize project teams to those strategies. Communicates program and/or project-specific priorities. Contributes to development, maintenance and approval of project plans. Delegates whilst retaining ownership, guides and supports team leads in prioritizing, trouble-shooting and contingency planning. Liaises with functional leads/managers to optimize performance and utilization of project team members. Functions as a point of escalation for project teams.
  • Strategy and Protocol Risk Evaluation Process (PREP) Facilitator: Partners with Project Manager and project team to assist team with continuous risk identification, management and risk control.
  • Ensures adherence to company SOPs, policies and guidelines at the project/program level. Assumes project leadership role in compliance with ICON processes and systems including escalation to relevant functional and operational management. Participation and attendance in bid defense process. Mentoring of other members of the project management team or functional leads, as required.
  • Manages project costs. Owns projections and actuals of units/hours analysis. Ensures that project team resource allocations are in line with budget and to achieve deliverables. Proactively identifies, negotiates and executes contract modifications ensuring out of scope activities are approved upfront via a contract modification. Leads presentation of financial reviews and is accountable for action item follow up. In cooperation with the project analyst, applies efficient management of project pass-through costs and investigates payments.
  • Provides project management leadership to cross-functional teams for all activities related to the initiation, planning, execution, monitoring and close-out of assigned projects. Ensures that all budgetary requirements, study timeframes and targets are met. Responsible for managing a portfolio consisting of high complexity, global, full-service projects.
  • Course Instructor: Successfully delivered Strategy Mindset Training to classes >50 attendees over a 12-week period.

Project Director 2

ICON, formerly PRA Health Sciences
04.2021 - 12.2023
  • Responsible for managing the ICON-Sponsor Project Management Office (PMO), a portfolio level team, supporting specific strategic client relationships. The PMO helps set forth unified vision, expectations, and processes for the current and future studies. The PMO team is involved with laying the groundwork for the sponsor/ ICON relationship and continues to support the portfolio across all PRA divisions (EDS, PP, RWS & SS)
  • Responsibilities include:
  • Participation and coordination of relationship workstreams
  • Development of the Playbook which details high-level standards and handoff mechanisms between the ICON SOPs and the sponsors functional requirements
  • Coordination of ICON Communications to internal and external stakeholders
  • Development and coordination of ICON change management activities
  • Strategy and PREP Facilitator: Facilitates key discussions to ensure project strategy is understood, operationalized and measured. Facilitates continuous risk identification, management and risk control.
  • Provides ongoing mentoring and training to continuously develop team and to achieve optimal performance and compliance with company systems, policies, and processes.
  • Creates and maintains an online knowledge management repository and toolkit to easily access the operational project teams.
  • Supports staff by using innovative thinking to resolve complex issues where fundamental principles do not clearly apply or where data appear to conflict.
  • Develops best practice tools and templates to assist with oversight and management of operational programs.
  • Responsible for defining governance objectives, implementing and tracking against appropriate portfolio metrics, as well as resolving process escalations.
  • Works closely with Quality Assurance, Business Development, and Functional Departments to provide guidance on all partnership activities.
  • Responsible for leading a Strategic Partnership Enablement Team for Large Pharma. The Partnership Enablement Team works alongside project teams to (1) support the set-up of the client’s specific portfolio needs, and (2) ensure a parallel focus remains on both ‘partnership set-up’ and ‘project start-up’ so that key deliverables meet timelines.
  • Key Accomplishments

Project Director 1

ICON, formerly PRA Health Sciences
03.2011 - 03.2021
  • Responsible for managing the PRA-Sponsor Project Management Office (PMO), a portfolio level team, supporting specific strategic client relationships. Details listed above under Project Director 2.
  • Responsible for owning and achieving interim and final contractual deliverables throughout the project life for assigned projects, according to the time, quality, scope and cost constraints.
  • Mentors other members of the project management team or functional leads.
  • Acts as lead contact for regional and/or project matters.
  • Manages project contractual deliverables; monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).
  • Acts as primary liaison with client; understands/manages/satisfies customer contractual, organizational and relationship needs/expectations.
  • Required to manage large national, international and/or particularly complex, multifaceted projects.
  • Proactively identifies, resolves, mitigates and escalates risks and/or issues.
  • Understands and manages client expectations and needs to achieve client satisfaction.
  • Leads and directs cross-functional team leaders and third parties; guides and supports team leads in prioritizing, trouble-shooting and contingency planning.
  • Key Accomplishments

Project Manager 2

ICON, formerly PRA Health Sciences
12.2006 - 02.2011
  • The responsibilities required of the Project Manager (PM) 2, include those listed in the PM 1 description, with increased scope, complexity and scale.
  • Key Accomplishments

Project Manager 1

ICON, formerly PRA Health Sciences
03.2004 - 12.2006
  • Interacted with all stakeholders to ensure comprehensive management of projects.
  • Coordinated and communicated project activities; produced project status reports and alerts management of impediments to progress; chaired project meetings.
  • Ensured that work complies with PRA’s Standard Operating Procedures (SOPs) and policies.
  • Served as the primary project contact for communication.
  • Performed risk assessments of projects and programs.
  • Maintained understanding of PRA’s general functions and systems.
  • Proactively identified, resolved/ mitigated and escalated risks and issues.
  • Responsible for owning and achieving interim and final contractual deliverables for assigned projects/ programs, according to the time, quality/ scope and cost constraints.
  • Provided regular reporting on project metrics, status of deliverables and risks/ issues with the associated management plan to clients.
  • Led and directed cross-functional teams and third parties/ vendors.
  • Guided and supported team leads in prioritizing, trouble-shooting and contingency planning.
  • Phase 2 global Parkinson’s disease program successfully brought to completion with all significant milestones achieved on schedule and subsequently FDA approved.
  • Key Accomplishments

Project Management Associate

ICON, formerly PRA Health Sciences
07.2002 - 03.2004
  • In collaboration with the Global Project Manager, developed all components of the Project Plan.
  • Ensured day to day study management within budgeted scope through reviewing and analyzing project financial reports.
  • Worked with each functional group to ensure they understood the scope of the contract and that they adhered to the defined budget.
  • Provided leadership and guidance to the project team members from other functional groups to ensure responsibilities were fulfilled in accordance with the project contract.
  • Key Accomplishments

Manager, Clinical Operations Assistants

CroMedica Inc.
09.2001 - 07.2002
  • Assigned COAs to projects and adjusted resources as necessary during the project lifecycle.
  • Provided mentoring and assistance with problem solving, professional development, education and training.
  • Interviewed and hired Clinical Operations Assistants (COAs).
  • Ensured staff were adequately trained by planning and implementing training programs for Clinical Operations Assistants.
  • Prepared and conducted new employee orientation.
  • Implemented 3 and 6 month performance reviews in addition to annual performance appraisals for the Clinical Operations Assistants (COAs) and COA Managers.
  • Assisted with workload and resource allocation.
  • Served as a liaison between CroMedica and the customer in relation to project administration issues.
  • Led and supervised the Clinical Operations Assistants (COAs).
  • Key Accomplishments

Clinical Operations Assistant

CroMedica Inc.
05.2000 - 09.2001
  • Assisted with the resolution of investigational site/ data queries.
  • Development and review of informed consent form templates.
  • Provided training for incoming Clinical Operations Assistants.
  • Performed investigative site recruitment/ feasibility, clinical status tracking, and in-house site management activities in accordance with the sponsor protocol and Standard Operating Procedures, ICH/GCP and all applicable regulatory guidelines.
  • Provision of general project related management support for all aspects of assigned projects.
  • Essential document collection, review, maintenance and close-out activities; ensuring that the sponsor and investigator obligations were met and in compliance with the local regulatory requirements and ICH/GCP.
  • Key Accomplishments

Education

BS - Life Science (Honors)

Queens University
Kingston, Ontario
06.2000

MBA - undefined

Queens University
Kingston, Ontario
05.2010

Skills

  • Problem-solving
  • Project management
  • Detail-oriented
  • Strategic planning
  • Client and Stakeholder management
  • Team leadership and direction
  • Critical thinking

Languages

English
Speaking Proficiency: High, Reading Proficiency: High, Writing Proficiency: High, Medical Records/Terminology Proficiency: Medium
French
Speaking Proficiency: Medium, Reading Proficiency: Medium, Writing Proficiency: Medium, Medical Records/Terminology Proficiency: None

Vendor Experience

  • Parexel, MEDQIA, BioTel Research, Bio-Imaging Technologies
  • Central Imaging Services
  • Covance, LabCorp, ACM, Q2, Quest Diagnostic, Quintiles, Central Pathology (Inova/DR. Zachary Goodman), Esoterix
  • Central Lab Services
  • Central Spirometry Vendor
  • Central Spirometry
  • INC, Cognizant
  • Clinical Data Management
  • Premier Research
  • Drug Packaging & Distribution
  • ERT
  • EDC / eDiary / e-PRO
  • Advarra
  • IRB
  • Parexel, Perceptive, Perceptive
  • IXRS
  • Meeting Protocol Worldwide
  • Meeting Planning Services
  • DAVA Oncology
  • SMO
  • Transperfect, Lionbridge, Transperfect
  • Translation Services

Timeline

Program Manager

ICON
01.2024 - Current

Project Director 2

ICON, formerly PRA Health Sciences
04.2021 - 12.2023

Project Director 1

ICON, formerly PRA Health Sciences
03.2011 - 03.2021

Project Manager 2

ICON, formerly PRA Health Sciences
12.2006 - 02.2011

Project Manager 1

ICON, formerly PRA Health Sciences
03.2004 - 12.2006

Project Management Associate

ICON, formerly PRA Health Sciences
07.2002 - 03.2004

Manager, Clinical Operations Assistants

CroMedica Inc.
09.2001 - 07.2002

Clinical Operations Assistant

CroMedica Inc.
05.2000 - 09.2001

MBA - undefined

Queens University

BS - Life Science (Honors)

Queens University

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Jennifer Earle