ADAM DUNN
NASHVILLE,TN
Summary
Project management professional with track record of delivering high-impact projects in diverse environments. Adept at driving project timelines and ensuring quality outcomes through strategic planning and execution. Highly collaborative, adaptable, and committed to team success and client satisfaction.
Overview
15
15
years of professional experience
Work History
Senior Project Coordinator
Fortrea
10.2021 - 02.2025
- Serve as primary support to the Project Lead for global studies
- Create and manage variance to required project plans
- Per SOPs, implement and monitor progress against project plans and revise, as necessary
- Oversee contracted milestones timelines, and key performance indicators
- Serve as key client and investigator site contact for assigned project responsibilities, establishing working relationships with client and site investigator project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
- Collaborate with the Project Lead to support with vendor management, financial oversight tasks like Standard Units forecasting, invoice review, and grant payment processing
- Escalation point for vendor issues as acting PM for the vendor over the last year and a half
- Monitor project scope, schedule, and costs to ensure all remain on track with the contract
- Facilitate weekly meetings with both internal departments and external vendors to discuss any risks or challenges the team or vendor may be facing
- Assist in financial oversight, including timesheet vs
- Budget analysis, vendor and sponsor contract financial tracking, reconciliation, and preparation of monthly financial reports and forecasts
- Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)
- Conduct Contract vs
- Study Plan reviews, maintain out of scope (OOS) work trackers, and document out of scope work within Change Order Forms
- Manage vendor relationships, ensuring proper escalation of OOS activities
- Regularly update and manage the actions, issues, and risks on projects
- Monitor and resolve protocol deviations and outstanding action items
- Ensure compliance through monthly updates of the Project Governance Tool and support in audit preparations
- Responsible for preparation, distribution and filing of all-site distributions, and newsletters; coordinating schedules for multiple project meetings in accordance with the project plan, and support of change management communications to team of system and process changes
- Maintain data integrity in Veeva QMS, manage CAPAs, and handle privacy incident reporting
- Support in closing audit/inspection CAPAs timely, manage TMF filings, and improve completeness metrics
- Prepared for audits and investigations by assisting in the development of storyboards to document potential study issues and support the timely closure of audit/inspection Corrective and Preventive Actions (CAPAs)
- Oversee lab kit expiration management, site activation tracking, and coordinate lab reports and custom SDV reports to support clinical operations, enhancing operational visibility and efficiency
Project Coordinator II
LabCorp
11.2020 - 10.2021
- Acted as primary support to the Project Lead, overseeing the creation, maintenance, and updating of project schedules using MS Project, CTMS, and various governance tools
- Collaborated with the Project Lead on financial management tasks, including TAR reviews, tracking and reconciling vendor and sponsor contract finances, and ensuring accurate final project financial reconciliations
- Assisted in conducting Contract vs
- Study Plan reviews, tracked out of scope (OOS) activities, and supported the creation of Change Order Forms
- Managed vendor relations in the absence of a dedicated Vendor Manager, escalating OOS issues to the Project Lead
- Updated the Xcellerate Risk Identification & Issue Resolution (RIIM) tool, ensuring all action items were resolved in a timely manner
- Maintained the completeness of the Risk Assessment Categorization Tool (RACT) using the Xcellerate Risk library and worked with the study team to manage protocol deviations documentation
- Monthly updates to the Project Governance Tool, actively working with the study team to identify, prevent, and resolve quality compliance issues
- Prepared for audits and investigations by assisting in the development of storyboards to document potential study issues and supported the timely closure of audit/inspection Corrective and Preventive Actions (CAPAs)
Start-up Associate
Covance
06.2019 - 10.2020
- Efficiently collected, reviewed, processed, and tracked regulatory and investigator documents to ensure compliance and readiness for study initiation in Siebel CTMS and GoBalto
- Engaged in negotiations for Investigative Site contracts and budgets, aiming to align study needs with site capabilities and expectations
- Prepared and managed submissions to Institutional Review Boards/Independent Ethics Committees (IRB/IEC), ensuring all ethical considerations were met for study commencement
- Maintained meticulous records of all required regulatory and investigator documents, ensuring all were accounted for throughout the study lifecycle
- Monitored and ensured that start-up and maintenance activities were on schedule, supporting the achievement of key study deliverables
Oncology Investigational Drug Certified Pharmacy Technician
Vanderbilt University Medical Center
07.2010 - 05.2019
- Regularly audited pharmacy drug binders to uphold study protocols and ensure patient safety
- Assisted Clinical Research Associates (CRAs) and Sponsors during Site Initiation Visits (SIVs) by demonstrating storage and temperature monitoring procedures for study products
- Managed scheduling for CRA monitor visits, assisting with query resolution during these visits to maintain study compliance
- Competently prepared both intravenous (IV) and oral medications for oncology patients
- Conducted inventory reconciliation, managing the disposal of expired products and ordering replacements to ensure continuous supply
- Maintained accurate billing records for dispensed study products, ensuring financial transparency
- Processed returned study products, documenting their status for full accountability
Education
Bachelor of Science - Marketing
Southern New Hampshire University
Manchester, NH04.2018
Skills
- Project Management
- Vendor Management
- Contract Negotiations
- Customer Support
- Performance Tracking
- Finance Reconciliation
- Invoice Management
- Budget Analysis
- Risk Assessment
- Microsoft Office
- Trend Analysis
- Issue Reporting
- Strategy Development
- Administrative management
- Project tracking
- Project scheduling
- Reporting skills
- Schedule management
- Project management
- Documentation management
Systemsexperience
- Siebel CTMS: 5 years
- Veeva: 5 years
- RIM: 4 years
- Roche CTMS: 4 years
- IGPS: 3 years
- Rave (EDC): 4 years
- Flat Iron (EDC): 1 year
- Almac (IxRS): 4 years
- Data Warehouse: 4 years
- Anaplan: 2 years
- SIP: 3 years
- Lablink: 3 years
- FileNet: 4 years
- UPS: 3 years
- DocuSign: 5 years
- Xcellerate Portal: 4 years
- BioTel: 1 year
- EndPoint: 1 year
- QuickBase: 3 years
- TransPerfect: 1 year
- TIDE: 3 years
- GoBalto: 1 year
Therapeuticexperience
- Cardiovascular: Risk Non-CV drugs - (Phase IIa)
- Endocrinology: Diabetes Mellitus - Type II - (Phase III)
- Endocrinology: Endocrinology - (Phase III)
- Pulmonary/Respiratory Chronic Respiratory Disorders COPD - (Phase III)
- Oncology: Skin Cancer Melanoma - (Phase III)
- Oncology: Lung Cancer NSCLC (Non-Small Cell Lung Cancer) - (Phase IIb)
- Oncology: Breast Cancer, Breast - (Phase IIb)
- Oncology: Skin Cancer Melanoma - (Phase I)
- Oncology: Lung Cancer - (Phase I)
- Oncology: Breast Cancer - (Phase I)
- Oncology: Cancer, lung, non-small cell - (Phase II)
- Oncology: Blood-based biomarker detection - (Phase III)
Languages
English
Native or Bilingual
Timeline
Senior Project Coordinator
Fortrea
10.2021 - 02.2025
Project Coordinator II
LabCorp
11.2020 - 10.2021
Start-up Associate
Covance
06.2019 - 10.2020
Oncology Investigational Drug Certified Pharmacy Technician
Vanderbilt University Medical Center
07.2010 - 05.2019
Bachelor of Science - Marketing
Southern New Hampshire University
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