Colleen McKenna, PMP
Cary,NC
Summary
Experienced in Project Management Setup gifted at navigating stakeholders and complex scenarios, creating new client partnerships, and working well in high-pressure environments. Certified Project Management Professional that manages global clinical trial setups. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Setup Specialist II
ICON PLC
04.2023 - Current
- Oversee project initiations and amendments amounting to $38 million in total budgets
- Act as functional lead for full-service study awards with cross- departmental collaboration
- Lead projects in respect to setup process improvement and serve as resource for other projects utilizing subject matter expertise
- Present solutions and establish best practices for new and complex protocol requirements
- Serve as primary liaison for project initiation to execution with sponsor and project manager until database publishing
- Communicate major decisions or timeline changes with Laboratory Project Manager and other laboratory staff as necessary
- Independently manage laboratory setup timeline
- Contribute towards maintenance of setup related documents and reference materials as necessary
- Oversee training of new hires and creating updated training materials
Setup Specialist
ICON PLC
06.2021 - 03.2023
- Led project initiations and amendments amounting to $12 million in total budgets
- Assigned to multiple new clients to establish partnership relations to build project pipeline
- Served as primary liaison on project initiation to execution with sponsor, internal and external stakeholders until database publishing
- Highlight any risks associated with study to sponsor and stakeholders as necessary
- Own document completion process
- Ensure all information and specifications are captured and are accurate by considering project requirements, sponsor requests, and company standards
- Communicate major decisions or timeline changes with Laboratory Project Manager and other laboratory staff as necessary
- Independently manage laboratory setup timeline
- Present solutions and establish best practices for new and complex protocol requirements
- Lead projects in respect to setup process improvement and serve as resource for other projects utilizing subject matter expertise
- Oversee new hires on setup processes and system capabilities
- Assist on their first projects as needed.
Study Startup Specialist
Firma Clinical Research
05.2021 - 06.2021
- Skilled at working independently and collaboratively in team environment.
- Assisted with creation and approval for study start-up documents with Project Managers and sponsors per study specific activities
- Attend and assist in sponsor study start-up meetings
- Point of reference for internal and external stakeholders during duration of setup
- Brainstormed ideas to develop and implement internal process improvement initiatives.
Home Trial Coordinator
Firma Clinical Research
10.2020 - 05.2021
- Responsible for management and oversight of in-home study visits for clinical trials
- Created and reviewed essential study start-up documents and organize/host teleconferences with sponsor, CROs, Central Lab and sites
- Provided study-specific training, materials and oversight to nurses and investigator sites for home trial visits
- Identified and negotiated contracts with in-home nursing agencies within budget constraints
- Provided invoice reconciliation to vendors and nursing agencies
- Acted as point of contact for nurses, Sponsors, CROs, and sites for coordinating efficient home health visits for subjects
- Developed and implemented internal process improvement initiatives and oversee training new coordinators.
Project Coordinator
Bioanalytical Services, LabConnect, Inc
05.2019 - 10.2020
- Contracted on behalf of Amgen as test site coordinator supporting scientists, clinical operations teams for Discovery Research and Phase I-IV trials
- Conducted in vivo studies for discovery research at multiple vendors
- Drafted protocols and reviewed formulation instructions
- Communicated with internal scientists for timelines, troubleshoot issues, and receive data
- Led setup of working with new vendor
- Created data monitoring plans and uploaded data files to data systems for multiple clinical trials biomarker testing with flow cytometry department
- Aided medicinal chemistry teams with overseeing processes for requesting raw materials
- Responsible for registering new compounds into database, performing invoice reconciliation, and communicating updates on compound synthesis to stakeholders
- Managed performance indicator testing for methods that support safety sample analysis
- Initiated testing with vendor and reviewed physician reports for data in acceptance for specimen testing accuracy
- Subject Matter Expert for Planisware PPM for multiple departments
- Restructured workflows for multiple programs with in vivo and medicinal chemistry.
Associate Initiation Manager II
LabConnect, Inc
07.2018 - 05.2019
- Worked as project lead for clinical trial setup and global expansion studies with partner laboratories
- Developed Statement of Work based on budget and protocol
- Wrote laboratory manuals and requisition forms for specific collection kits for site collections
- Cross trained all internal departments for study specific information
- Tracked department metrics that enabled better expense tracking
- Partnered with senior managers to develop user manual for global setup process with partner laboratories especially relating to peripheral blood mononuclear cell procedures
- Created demonstration materials and information for bid defenses.
Associate Initiation Manager I
LabConnect, Inc
08.2017 - 07.2018
- Aided senior-level managers in study setup and lead low complexity studies
- Developed Statement of Work based on budget and protocol
- Wrote laboratory manuals and requisition forms for specific collection kits for site collections
- Sourced clinical supplies and logistics materials
- Assisted on multiple expedited studies by working with other departments to have materials delivered on time for site initiation.
Investigator Support Services Representative
LabConnect, Inc
05.2017 - 08.2017
- Handled customer inquiries and concerns including site queries and specimen condition
- Accessioned and prepared samples to be sent to laboratories for analysis
- Performed quality checks on requisition forms in database
- Trained new hires on department processes including quality checks, sample accessioning, daily tasks, and querying process
- Enhanced workflow efficiencies that resulted in reduced department labor costs.
Education
Bachelor of Science - Health Sciences
East Tennessee State University
Johnson City, TN2017
Skills
- Project Milestone and timeline development
- Process Improvement
- Document development
- Experience with SmartSheet, Planisware PPM, STARLIMS, Microsoft 365, Microsoft SharePoint
- Client Relations
- Conflict Management
- Laboratory setup
Certification
Project Management Professional (PMP), Project Management Institute, 2022Essentials of Project Management, University of Chicago, 2021Clinical Trial Management and Regulatory Compliance, University of Chicago GrahamSchool, 2018
Timeline
Setup Specialist II
ICON PLC
04.2023 - Current
Setup Specialist
ICON PLC
06.2021 - 03.2023
Study Startup Specialist
Firma Clinical Research
05.2021 - 06.2021
Home Trial Coordinator
Firma Clinical Research
10.2020 - 05.2021
Project Coordinator
Bioanalytical Services, LabConnect, Inc
05.2019 - 10.2020
Associate Initiation Manager II
LabConnect, Inc
07.2018 - 05.2019
Associate Initiation Manager I
LabConnect, Inc
08.2017 - 07.2018
Investigator Support Services Representative
LabConnect, Inc
05.2017 - 08.2017
Bachelor of Science - Health Sciences
East Tennessee State University
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