Duane Harbaugh
Lawrence,New Jersey
Overview
25
25
years of professional experience
Work History
Site Management Associate II
ICON plc
11.2023 - 12.2024
- Ensure TMF completeness and accuracy based on client SOPs and regulatory requirements
- Maintain study level TMFs including planning and setup, QC Reviews, based analysis and vendor oversight
- Conduct content review of a variety of documents while maintaining consistency and attention to detail
- Prioritize work accordingly to meet departmental needs and work towards and meet deadlines with moderate supervision
- Generate metrics for department and study team usage supporting TMF completeness, accuracy and quality
- Participate in inspection readiness reviews and preparation activities
- Provide training as applicable to TMF stakeholders
- Participate in the onboarding of new staff
- Participate in straightforward projects that may require cross-functional collaboration or involve coordinating system updates
TMF Lead II
Syneos Health
04.2021 - 10.2023
- Provides oversight of all electronic Trial Master File (TMF) management activities for assigned projects from award to final transfer
- Drives and oversees successful completion of all TMF scoped deliverables including TMF Plan development, TMF set-up, monitoring document submissions/publishing and processing, oversight and coordination of Quality Control processes, and internal and external audit representation
- Involved in monthly project reviews evaluating operational and financial key performance indicators
- Attends meetings as TMF Subject Matter Expert and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF
- Collaborates with the Project Lead and Functional Leads to ensure TMF documentation is submitted/published in a timely manner and with high quality in order to maintain the TMF in an audit-ready state
- Follows up on non-compliance
- Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME as applicable to the project
- Designs and delivers study specific TMF training in various formats via teleconference, video conference, or in person
- Generates and provides metric reports to the project teams
- Participates in project-specific audits/inspections to ensure ongoing readiness of the TMF
Senior Project Specialist
Syneos Health
09.2020 - 04.2021
- Set-up, maintain and close out project files and study information ((e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems
- May lead internal meetings as directed by the PL Prepares and distributes meeting minutes and action items for internal meetings (sponsor, trusted process, functional, investigator meetings)
- Follows up with team members on action items to closure
- Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL
- Ensure all study documents are archived based on the appropriate guidelines and policy
- May serve as project representative for internal and external audits
- Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution actionable issues
- May mentor and train Project Specialists
Project Coordinator
Syneos Health (formerly INC Research/inVentiv Health Clinical)
06.2016 - 09.2020
- Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems
- Attends, participates, prepares and distributes meeting minutes and action items for both internal meetings (sponsor, trusted process, functional, investigator meetings)
- Follows up with team members on action items to closure
- Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status
- May contact site staff as needed for critical information
- Provide administrative support to Project Leads and functional leads
- Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues
Accounts Receivable Coordinator
inVentiv Health Clinical
06.2013 - 06.2016
- Prepare and process invoicing of service fees, grants and pass-through costs for high volume projects weekly, bi-weekly and monthly
- Compile and generate summaries of expenses and detail backup for projects
- Communicate and collaborate with Project Managers and Project Financial Analysts to secure approvals for invoicing of expenses
- Reconciliation of client files within Peoplesoft
- Correspond with clients and respond to inquiries
- Prepare billing forecasting for entire global company on a weekly basis
- Prepare and gather final billing numbers for entire global company monthly
- Process journal entries to move expenses the US based company to UK based company to process
- Correspond with Credit and Collections on issues of invoices and help correct the issues with Peoplesoft and resubmit invoices to clients
- Run weekly billing pull-in process
- Update client list as needed for distribution within company
- Conduct various audits between payroll, accounts receivable, accounts payable and billing systems
- Maintain audit of rates and Management Fees for clients and assist with contract compliance audits
- Participate in annual audit process
- Maintain accurate billing records and assists with problem accounts utilizing an issue log
- Generated Credit/Rebill and Unbilled AR Reports
Billing Coordinator
Drinker Biddle & Reath LLP
12.2013 - 03.2013
- Coordinate distribution of time and expenses for matters to attorneys
- Edit and generate invoices for attorneys per guidelines set with each client
- Submitted invoices through electronics billings systems
- Managed Trust Account information
- File and maintain invoices after they were sent to clients
- Maintained and distributed petty cash to the office
Accounts Payable Coordinator
Verizon Global Solutions, Inc.
01.2000 - 11.2003
- Entered and approved expenses for company globally
- Maintain ledger of Value Added Tax (VAT) for several countries to recoup those expenses
Timeline
Site Management Associate II
ICON plc
11.2023 - 12.2024
TMF Lead II
Syneos Health
04.2021 - 10.2023
Senior Project Specialist
Syneos Health
09.2020 - 04.2021
Project Coordinator
Syneos Health (formerly INC Research/inVentiv Health Clinical)
06.2016 - 09.2020
Billing Coordinator
Drinker Biddle & Reath LLP
12.2013 - 03.2013
Accounts Receivable Coordinator
inVentiv Health Clinical
06.2013 - 06.2016
Accounts Payable Coordinator
Verizon Global Solutions, Inc.
01.2000 - 11.2003
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