Karen R. Poole
Burlington,KY
Summary
Motivational leader and organizational problem-solver with advanced supervisory, team building and customer service skills. Experience stepping into roles and quickly making positive changes to drive company success. Focused on using training, monitoring and morale-building techniques to maximize employee engagement and performance.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Project Launch Manager & Sr.Project Launch Manager
Premier ResearchS
Morrisville, NC
06.2017 - 08.2024
- Managed and oversaw project launch activities for various functional groups, such as Clinical Operations, Study Start Up, Data Management, Statistics, Medical Writing, Medical Monitoring, and Pharmacovigilance. Ensured timely, cost-effective, and high-quality project launches for assigned projects.
- Oversaw the PLM resourcing and communicated technical direction to project launch team for successful project launches.
- Implemented cross-functional strategies for studies in startup by utilizing prior experience to effectively lead PLMs.
- Managed critical path elements of the launch process, identifying risks and developing mitigation plans. Supported implementation of these plans.
- Efficiently guided and supervised project launch processes as designated Project Launch Manager.
- Worked in the capacity of a full-time Senior Project Manager according to business needs.
- Coordinated efforts for the launch within Premier Research, the Sponsor and various third-party vendors
- Applied best practices and lessons learned to successfully develop, plan, and launch projects.
- Collaborated with Project Leader to identify and communicate project launch risks, ensuring their accurate documentation and effective management
- Established and maintained full communication across the project team, interacting with functional groups throughout Project Launch activities from award to completion of Startup.
- Establish standard core project plans, documents, templates, and project timelines across multiple functional departments.
- Ensured adherence to project budget and scope of work during startup.
- Proactively managed requests for out-of-scope work, escalating them promptly to the Project Leader.
- Ensure that team training aligns with the protocol and/or project requirements, encompassing therapeutic, protocol-specific, and procedural training.
- Prepared for both Internal and external Kick-Off Meetings, identifying necessary resources, developing draft project plans and timelines , collating client input queries, and activating key systems including Working Directory, SFTs, study email boxes, and LMS.
- Facilitated Internal Kick-Off Meetings and project Startup teleconferences to ensure timely adherence.
- Monitored and updated timelines for assigned projects, ensuring the Project Leader is constantly informed of progress.
- Monitored project deliverables for quality and addressed any issues with team members.
- Led resolution of project conflicts and implemented corrective/preventative actions to mitigate potential issues.
- Ensured appropriate transition planning for completion of the Startup phase.
- Contributed to critical efforts and projects that drive continuous growth within the company.
Project Manager and Senior Project Manager
Covance
Princeton, NJ
03.2011 - 06.2017
- Led core project team, enhancing team's capability to lead extended or complete project teams.
- Ensured effective cross-functional teamwork among project team members, including internal and external ancillary services.
- Managed vendor partnerships and ensured optimal performance
- Managed and coordinated Global Team activities
- Served as go-to person for resolving CRA issues
- Successfully addressed and resolved conflicts as needed
- Monitored project schedule and scope to ensure adherence to timelines and objectives
- Implemented and followed preapproved procedures for any deviations
- Met project deliverables by actively participating in quality assurance and risk management activities as per the standards of both Covance and clients
- Ensured adherence to professional standards and SOPs by all staff allocated to assigned project(s).
- Initiated improvements to enhance efficiency and quality of assigned project work.
- Prepared and actively participated as operational lead in internal Project Review meetings.
- Provided performance feedback of team members to their respective supervisors.
- Active presence in both external and internal meetings.
- Defined and managed project resource needs, and established succession plans for key resources.
- Devised and implemented project plans in compliance with company guidelines.
- Implemented and monitored progress against project plans, making necessary revisions.
- Managed all client communication and served as primary contact for assigned projects
- Established working relationships with client project teams, resulting in increased client satisfaction and operational excellence.
- Prepared and delivered presentations for new business in collaboration with relevant departments.
- Achieved financial performance targets for assigned project(s)
- Managed client project metrics.
Site Management Associate
REGISTRAT-MAPI (Aerotek Contractor)
Lexington, KY
04.2010 - 02.2011
- Assist in managing clinical and regulatory aspects of assigned Phase IIIb-IV studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA or other local regulations and ICH/GCP guidelines
- Actively participate in planning, implementing and managing the start-up, execution and close-out activities of assigned studies
- Ensure the timely and appropriate collection, review and submission of essential documents as required
- Assist with the preparations and coordination of Investigator Meetings and attend and present at Investigator Meetings as required
- Assist with the development of study manual, monitoring conventions, telephone scripts, tracking forms and other study related documents
- Conduct and assist with administrative activities as a member of the project team
- Perform site management and in house study monitoring tasks for assigned sites
- Work with the sponsor and project manager, help to ensure optimal selection of Investigators and sites
- Act as the primary contact for site interactions and communications
Senior & Lead Clinical Research Associate
Kendle International, Inc.
Cincinnati, OH
01.2006 - 02.2010
- Provided direction and guidance to project team, ensuring successful project completion
- Maintained oversight of assigned CRA's, ensuring adherence to project timelines and quality standards.
- Achieved monthly balance by reviewing and managing the monitoring budget for a high-profile $25 million oncology sponsor study, where it constituted the majority of overall expenditures
- Reported budget review findings to Project Leader; collaborated with Project Leader on necessary budget adjustments and communicated changes to accounting department
- Demonstrated exceptional leadership throughout a 10-year global project, successfully achieving on-time completion and maintaining a profitable outcome
- Managed lead CRA activities for 75 sites across the US, Canada, and Europe.
- Worked closely with Data Management team to successfully lock database on time
- Facilitated cross-functional meetings with CRO, project Sponsor, and external vendors.
- Managed a team consisting of CRA I, CRA II, and administrative personnel while providing clinical leadership and technical guidance.
- Created and updated monitoring plans as necessary during assigned projects.
- Facilitated weekly meetings to mentor and train associates, resulting in effective onboarding of new hires.
- Developed corrective action plans for CRA staff to address job performance deficiencies and promote success.
- Conducted on-site training sessions and supervised sign-off visits for CRA I staff
- Drove project success through comprehensive administration of activities related to monitoring functions in Phase II-IV Clinical Research studies, while acquiring deeper understanding of Good Clinical Practices and relevant regulations.
- Contributed to the preparation and delivery of BID Defense for clients.
- Directed study site activities to maintain the integrity of clinical data according to applicable regulatory guidelines, SOPs, and PSOPs.
Clinical Research Associate I & II
Kendle International, Inc.
Cincinnati, OH
04.2002 - 01.2006
- Executed project tasks for Phase II-IIIb clinical research studies, elevating comprehension of drug development procedures, Good Clinical Practices, and applicable regulations
- Provided clinical and technical support to CRA I, CRA II, and administrative personnel.
- Completed on-site training, as well as visit sign-off, for CRA I staff.
- Successfully performed monitoring, Pre-Study, Initiation and Close-Out visits as part of study activities.
- Achieved resolution of queries and in-house audit reviews by collaborating with site and CRO staff.
- Assisted in the development and implementation of patient enrollment plans for research sites.
- Ensured adherence to applicable regulatory guidelines and SOPs/PSOPs while managing study site activities for maintaining the integrity of clinical data.
Regulatory Specialist & Sr. Regulatory Specialist
Kendle International, Inc.
Cincinnati, OH
09.1997 - 04.2002
- Collaborated with project Sponsors to ensure fulfillment of expectations regarding site identification, regulatory document collection, and site activation.
- Supervised and provided guidance to Regulatory Specialist I Associates and Regulatory Assistants in their assigned projects involving Phase II-IV clinical research studies
- Served as a mentor to enhance the skills of Regulatory Specialists
- Managed study-specific document filing requirements, developing checklists, overseeing data entry and filing processes, submitting to FDA, and tracking/distributing SOPs.
- Assisted an Australian Sponsor in successfully executing their inaugural US project while adhering to FDA regulations during study start-up
- Reviewed monthly utilization for both Regulatory Specialist and Regulatory Assistant
- Provided support to colleagues and adapted responsibilities when necessary.
- Maintained close working relationship with CRO personnel and sponsors, ensuring highest quality maintenance of study-specific documentation.
- Created and delivered new associate training programs on Study Start-Up and GCP/ICH guidelines organization-wide.
- Developed new methodologies to enhance process efficiencies, foster interdepartmental knowledge sharing, and incorporate lessons learned from prior projects.
- Performed annual and semi-annual performance evaluations for associates in the roles of Regulatory Specialist and Regulatory Assistant.
- Provided performance counseling when necessary.
- Collaborated with Project Managers and Clinical Research Associates to determine site readiness for on-site Pre-Study assessment visits.
- Reviewed Protocols for the creation and review of Subject Informed Consent documents
- Ensured Subject Informed Consent documents met GCP, FDA, and ICH guidelines.
- Prepared and collected regulatory documents ensuring completeness and accuracy
- Attended and presented at Investigator Meetings to support timely completion of regulatory documents
- Managed submissions and ongoing updates to Central IRBs on behalf of Sponsors and Clinical Research sites, ensuring compliance with FDA GCP and ICH regulations.
- Coordinated communication with physician's offices to facilitate information transfer and monitor the status of outstanding documents.
Education
College-Preparatory Curriculum -
Villa Madonna Academy
Villa Hills, KY01.1989
Some College (No Degree) - Medicinal and Pharmaceutical Chemistry
Thomas More College
Crestview Hills, KYSome College (No Degree) - Medicinal and Pharmaceutical Biology
Northern Kentucky University
Highland Heights, KYSkills
- Technical knowledge
- Cross-functional team leadership
- Sales Enablement
- Timeline Management
- Business Development
- Employee Development
- Fiscal Management
- Policy administration
- Budget Management
- Cost Control
- Schedule Management
- Project Planning
- Process Improvement
- Customer Service
- Scheduling and Coordinating
- Positive Attitude
- Team building
- Financial Management
- Multitasking
- Computer Skills
- Onboarding and Orientation
- Negotiation
- Continuous Improvement
- Team Leadership
- MS Office
- Adaptability
- Training and Development
- Professional and Courteous
Certification
- May 2011 Certified Project Manager through PLMG Boot Camp
Languages
English, Native
Affiliations
- Ms. Poole volunteers at various other local fundraisers, community support fellowship events for children and adults in need.
- Ms. Poole particularly enjoys lending her project management skills to assist in a variety of volunteer activities outside of work
Biography
Karen Poole has 27 years of experience in Clinical Research. Ms. Poole was recently a Senior Project Launch Manager and sometimes took on the role of full-service Project Manager when the need for her was requested. She has been in Project Manager positions over the last 13 years leading Phase I through IV core project teams on projects with as few as 1 site in one country to >350 sites in 36 countries. Ms. Poole is often commended by her peers and senior management for her enthusiastic ability to lead projects through challenges. She has always received complimentary feedback from her team members who have worked for and with her. These compliments range from her strengths as a mentor, a team member to her consistent positive attitude. Karen really enjoys opportunities to find ways to make processes more efficient. Throughout her career, she has enjoyed training and mentoring others. In addition to her work in Project Management, Ms. Poole has worked in a variety of CRO roles, which enhances her ability to lead cross-functional teams. In addition to holding clinical leadership positions, Ms. Poole was a CRA, a Senior Regulatory Specialist and a trainer. While in these roles, she was responsible for recruiting, hiring, orientation, performance evaluation, and career development of her direct reports. As part of her duties, Ms. Poole developed and delivered training in her area of expertise including GCP and ICH guidelines to new hires in her department and across the organization. These experiences were both personally and professionally rewarding for her. In addition to volunteering at fundraisers, Ms. Poole also helps children and adults in need at various community support events. As part of her volunteer activities outside of work, she particularly enjoys lending her project management skills.
References
References available upon request.
Timeline
Project Launch Manager & Sr.Project Launch Manager
Premier ResearchS
06.2017 - 08.2024
Project Manager and Senior Project Manager
Covance
03.2011 - 06.2017
Site Management Associate
REGISTRAT-MAPI (Aerotek Contractor)
04.2010 - 02.2011
Senior & Lead Clinical Research Associate
Kendle International, Inc.
01.2006 - 02.2010
Clinical Research Associate I & II
Kendle International, Inc.
04.2002 - 01.2006
Regulatory Specialist & Sr. Regulatory Specialist
Kendle International, Inc.
09.1997 - 04.2002
College-Preparatory Curriculum -
Villa Madonna Academy
Some College (No Degree) - Medicinal and Pharmaceutical Chemistry
Thomas More College
Some College (No Degree) - Medicinal and Pharmaceutical Biology
Northern Kentucky University
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