Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Generic

Lindsay Allison

Bristol

Summary

Focused project manager bringing several years of developing continuous improvements throughout planning and implementation phases of projects. Demonstrated history of establishing and enforcing adherence to standards of excellence. Well-versed in mentoring and guiding associates to exceed client and stakeholder expectations. Accustomed to cultivating innovative ideas and encouraging new ideas that drive company growth.

Overview

11
11
years of professional experience

Work History

Project Manager

ICON
Raleigh
01.2023 - Current
  • Act as the Program Manager for government-funded projects within the ICON Government and Public Health Solutions Group.
  • Oversee studies within the program while providing administrative support, direct client support, and financial oversight.
  • Ensures adherence to company SOPs, policies, and guidelines at the project level.
  • Assumes a project leadership role in compliance with PRA processes and systems, including escalation to relevant functional and operational management.
  • Participation and attendance in the 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 the budget, and to achieve deliverables.
  • Proactively identifies, negotiates, and executes contract modifications, ensuring out-of-scope activities are approved upfront via a contract modification.
  • In cooperation with the project analyst, applies efficient management of project pass-through costs and investigators' payments.
  • Manages project contractual deliverables.
  • Proactively identifies risks and issues through ongoing review of project progress and metrics, and implements adequate follow-up actions to ensure mitigation/resolution is in place and adherence to the contractual agreement (time, quality/scope, and cost deliverables).
  • Leads the presentation of internal project status reviews and is accountable for action item follow-up.
  • Leads and directs a cross-functional team and third parties/vendors.
  • Able to conceptualize and articulate dynamic operational strategies, then mobilize project teams to implement those strategies.
  • Communicates project-specific priorities.
  • Contributes to the development, maintenance, and approval of project plans.
  • Guides and supports team leads in prioritizing, troubleshooting, and contingency planning.
  • Liaises with functional leads, managers, and project team members to optimize performance and utilization.
  • Functions as a point of escalation for project teams.
  • Acts as the primary liaison with the client.
  • Understands and manages client contractual, organizational, and relationship needs and expectations.
  • Chairs and leads customer meetings, acts as the lead contact for regional-level matters, and/or as the primary project manager.
  • Provides regular reporting on project metrics, the status of deliverables, and risks/issues with the associated management plan to the client.

Project Manager II

Premier Research
Morrisville
08.2022 - 01.2023
  • Developed, prepared, and executed project plans for all phases of the project lifecycle, including quality, risk management, and proactive contingency plans, ensuring that issue escalation and resolution are clear.
  • Ensured appropriate transition planning and stakeholder communication for any change in staff.
  • Developed strong relationships with current clients to generate new and/or add-on business.
  • Assisted in business development activities, including leading proposal presentations in partnership with business development and strategic drug development.
  • Identified and managed the scope of work, including recognizing and negotiating changes across all functional areas, and securing Change Orders.
  • Provided accurate information to ensure timely invoicing, and allow for accurate forecasting.
  • Reviewed and approved project expenses, and ensured all study-related contractual and budgeting issues were addressed.
  • Supported study audits, and responds to audit reports.
  • Created and implemented project documents and tools.
  • Oversaw project documentation, ensuring Trial Master Files are completed by the functional groups, and are audit ready.
  • Monitored timelines and clearly communicated timeline changes, both internally and externally, as applicable.
  • Facilitated team training in accordance with protocol and/or project requirements, including therapeutic, protocol-specific, and process training.
  • Chairs internal project team meetings and teleconferences.
  • Ensured that adequate resourcing is available to meet project deliverables and milestones.
  • Ensured that effective communication is maintained, and that project status reports and monthly progress reports are provided both internally and externally.
  • Ensured adherence to the project budget and scope of work to realize project profitability.
  • Responsible for overall project delivery, while leading, planning, organizing, and overseeing all activities related to the execution of clinical trials that are moderate to large in size and complexity, and take place within multiple regions.
  • Ensured customer-focused leadership from inception to execution, through completion, to achieve on-time, on-budget, high-quality project results.
  • Successfully managing and coordinating efforts assigned to all members of the project team to support milestone achievement and overall project delivery.
  • Collaborated with the client's senior-level and project team personnel.
  • Presented at Investigator Meetings.

Project Launch Manager

Premier Research
Morrisville
02.2021 - 08.2022
  • Successfully launched newly awarded clinical trials while avoiding the common pitfalls that place key milestones in jeopardy.
  • Lead multi-functional teams through this critical part of the clinical trial lifecycle to ensure customer satisfaction
  • Responsible for the on-time, on-budget, high-quality delivery of the project launch, with the objective of meeting key milestones and goal-setting, and laying the groundwork for continued success throughout the life of the study.
  • Tracked and reviewed timelines for all project launch activities for assigned projects, and ensured that the project leader was kept up to date with the latest status.
  • Conducted internal kick-off meetings and internal and external project startup teleconferences to ensure adherence to timelines.
  • Prepared for internal and external kick-off meetings, including, but not limited to, ensuring necessary resources are identified, developing draft project plans and timelines, collating questions that require input from the client, and ensuring key systems, including the Working Directory, SFTs, study email boxes, and LMS, are activated.
  • Ensured team training is in accordance with protocol and/or project requirements, including therapeutic, protocol-specific, and process training.
  • Ensured adherence to the project budget and scope of work during startup.
  • If out-of-scope work is requested, ensure escalation to the Project Leader.
  • Established standard core project plans, documents, templates, and project timelines across multiple functional departments; reviewed and ensured drafted plans developed by functional leads are submitted to clients prior to Kick-Off Meetings and fully signed off by Premier and Sponsor following the meeting.
  • Established and maintained full communication across the project team by interacting with functional groups for project launch activities from award through completion of startup; facilitated internal cross-functional communication, including but not limited to Finance, Business Development, Strategic Development, and Regulatory departments until the end of startup.
  • Communicated project launch risks to the Project Leader so that they may be included in the risk log and managed appropriately.
  • Ensured adequate resources were available to meet launch deliverables and milestones.
  • Management and oversight of the project launch activities of functional groups that comprise the project team including, but not limited to: Clinical Operations, Study Start Up, Data Management, Statistics, Medical Writing, Medical Monitoring, and Pharmacovigilance to ensure timely completion of all tasks related to startup.

Global Site Activation Lead

ICON
Blue Bell
09.2017 - 02.2021
  • Operations Management: Oversaw day-to-day delivery for all aspects of site activation in the project assigned.
  • Excellence in the client relationship: optimize opportunities for successful delivery of the project of the benefit of the client and of ICON
  • Accountable for the management of sponsor expectations and ensuring compliance with ICON/Sponsor KPIs, ICON/Sponsor SOPs, reporting norms, appropriate regulations, and ICON's quality standards.
  • Accountable for the risk management and mitigation strategies within site activation to ensure timely delivery.
  • Ensured stringent oversight of the project in terms of timely and quality delivery of key milestones, and that the impact of missed deliverables is clearly and timely communicated to all key stakeholders.
  • Accountable for driving and accelerating the activation of investigative sites in line with, or ahead of, the study's contractual timelines, budgeted resources, quality output, and sponsor expectations.
  • Working cross-functionally to ensure that the sites and countries optimize the accelerated delivery of the project.
  • Primary study start-up points of contact for complex, global projects.

Regulatory & Site Services Specialist II

Chiltern
Bristol
10.2015 - 09.2017
  • Acted as backup lead for global studies when the global startup lead was unfamiliar with U.S. and Canadian processes.
  • Responsible for the submissions of Clinical Trial Applications, Amendments, and Notifications to Health Canada to ensure competent authority approval of clinical studies in Canada.
  • Responsible for the completion of U.S. and Canada start-up activities while adhering to the project timeline and start-up budget set forth.
  • Feasibility and site identification coordination, essential document collection for critical document review prior to IP release, IRB submission, and site close-out activities.

Project Management Associate

Chiltern
Bristol
02.2015 - 10.2015
  • Responsible for providing project management assistance to the study project managers by assisting with the drafting of study plans, coordinating timelines, reviewing budgets with the study team, and setting up and coordinating kick-off, internal, and external meetings.
  • Responsible for investigator site payments while completing study payment request forms for submission to the accounts payable group.

Clinical Trial Associate

Chiltern
Bristol
01.2014 - 02.2015
  • Responsible for serving as the clinical trial point of contact for multiple duties, such as meetings, site outreach, filing, coordination of study binders, and collecting documents from sites and sponsors as needed.
  • Duties carried out as required by the Line Manager and/or Project Manager, and in accordance with SOPs.
  • Attend all study meetings, and record minutes while ensuring the study task log is up to date and eventually completed.
  • Responsible for providing project assistance to multiple clinical project teams, sponsors, sites, and vendors in multiple therapeutic areas.

Education

Bachelor of Arts - Organizational Management

Virginia Intermont College
Bristol
12-2002

Skills

  • Project management
  • Financial management
  • Risk assessment
  • Stakeholder communication
  • Contract negotiation
  • Regulatory compliance
  • Resource allocation
  • Team leadership
  • Process improvement
  • Client relationship management
  • Quality assurance
  • Change management
  • Time management
  • Meeting facilitation
  • Project scope analysis
  • Forecasting
  • Cost reduction and containment
  • Contract development
  • Presentations
  • Budget preparation
  • Vendor management

Affiliations

  • Co-Chair of The American Cancer Society Making Strides Committee, Northeast TN and Southwest VA

Timeline

Project Manager

ICON
01.2023 - Current

Project Manager II

Premier Research
08.2022 - 01.2023

Project Launch Manager

Premier Research
02.2021 - 08.2022

Global Site Activation Lead

ICON
09.2017 - 02.2021

Regulatory & Site Services Specialist II

Chiltern
10.2015 - 09.2017

Project Management Associate

Chiltern
02.2015 - 10.2015

Clinical Trial Associate

Chiltern
01.2014 - 02.2015

Bachelor of Arts - Organizational Management

Virginia Intermont College

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