BRIANA DI GIULIO
Montreal,Canada
Summary
Experienced clinical research professional with expertise in oncology and cardiovascular trials. Strong focus on trial start-up, site activation, and regulatory compliance. Proven ability to coordinate stakeholders, manage budgets, and leverage technology for program efficiency. Known for proactive communication and exceptional problem-solving skills. Builds strong relationships and consistently achieves successful outcomes.
Overview
5
5
years of professional experience
Work History
Site Activation Specialist
IQVIA Inc.
02.2024 - Current
- Activated sites before target, achieving significant bonuses from sponsors on multiple high priority studies.
- Arranged for sites to be importers of record to ensure deadlines were kept, tasks included but not limited to ensuring proper brokerage of IP and proper contract terms were in place.
- One of the most compliant in the team with TMF compliance and key metrics such as Essential Document Pack Approval and Site Ready to Enroll dates,
- Perform feasibility and site activation in assigned studies for investigative sites
- Submit regulatory documents to regulatory authorities on behalf of sites
- Review documents for completeness, consistency and accuracy, under guidance of senior staff
- Prepare site documents, reviewing for completeness and accuracy
- Distribute completed documents to sites and internal project team members
- Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information
- Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents
Program Coordinator, Oncology Clinical Research Program
St. Mary's Hospital Center
07.2023 - 12.2023
- Developed, updated and implemented program SOPs and Work Instructions (WI)
- Coordination of timely data transfers and adherence to study deadlines
- Monitor implementation of program standard operating policies and procedures
- Trial-specific management, duties include coordination and liaison with study site staff, CROs, sponsors, data management entities, and other internal departments or external vendors involved with the conduct of the clinical trial
- Management of Study start-up, site activation (including scheduling and planning SIV), maintenance (monitoring visits) and closeout (close out visits)
- Coordinate program communications, schedule and organize program-related meetings and events
- Oversee the program budget, provide support to the Clinical Trial Administrator, including but not limited to: tracking billing, payments and other financial transactions
- Create and maintain program records, reports, presentations and proposals
- Development and maintenance of trial-specific documentation, including ensuring that all documents are archived according to regulatory requirements
- Ensuring trial compliance with SOPs, applicable regulations and trial-specific protocol
- Providing timely and complete responses to study team, keeping trackers and using other tools to keep track of daily and long-term tasks completion in a timely fashion
Product Specialist
Montrium Inc
02.2022 - 01.2023
- Manage the onboarding projects with external clients and provide technical training on Montrium products
- Maintain client relationships by acting as the main point of contact during technical onboarding, from contract signature to provision of support
- Prepare technical documentation and training material, assist with User Acceptance Testing, and perform testing of use cases
- Interact with the development group during the system development process and running of test cases to ensure application readiness
- Deployment of client applications in Production and Quality environments and configure client environment settings based on the outcome of workshops
- Troubleshoot technical issues and identify modifications needed in existing applications to meet changing user requirements
- Maintain project documentation, including project schedule and ensure client satisfaction through the achievement of project objectives
- Identify and manage project issues, risks, and changes
- Provide technical training to client Super Users on Montrium products using self-serve materials
Clinical Projects Assistant
AbbVie Corporation
04.2021 - 12.2021
- Performed in-depth review of informed consent forms and made edits and changes where necessary
- Served as a point of contact between study sites for inquiries relating to Informed consent forms
- Brought forth a strong ability for multitasking and prioritizing tasks
- Worked in collaboration with other team members to achieve success
- Collaborated with the legal team to review and the sponsor's stance in language for informed consent forms
- Collaborated with the study teams to ensure accurate and precise information is relayed to patients through informed consent forms
- Prepared Study Start Up packages to send out to study sites
- Prepared Submissions for Central Research Ethics Board
Patient Support Coordinator
Innomar Strategies
11.2019 - 04.2021
- Pioneered new team for the program, and company
- Created new processes and training programs
- Scheduled and coordinated shipments of medication to Innomar Clinics
- Prepared custom entries and deliveries of medications delivered to local pharmacies
- Initiated and Supported Process Improvements
- Managed any and all logistics from supplier to customer
- Brought forth a compassionate and helpful attitude at all times
- Reviewed Post Injection Reports, ensuring patients received medication, and at the correct dose
- Adverse Event Reporting and Data Entry
- Creating and Managing Purchasing Orders
- Monitored daily reminder call logs
Education
Bachelor of Science - SPECIALIZATION, BIOLOGY
CONCORDIA UNIVERSITY
Montreal, QCSkills
- TMF management and compliance
- Regulatory Adherence
- Regulatory Documentation Proficiency
- Cross-Functional Project Coordination
- Vendor Management
- Standard Operating Procedures
- Mentoring Others
- Collaboration
Languages
English
Native or Bilingual
French
Full Professional
Timeline
Site Activation Specialist
IQVIA Inc.
02.2024 - Current
Program Coordinator, Oncology Clinical Research Program
St. Mary's Hospital Center
07.2023 - 12.2023
Product Specialist
Montrium Inc
02.2022 - 01.2023
Clinical Projects Assistant
AbbVie Corporation
04.2021 - 12.2021
Patient Support Coordinator
Innomar Strategies
11.2019 - 04.2021
Bachelor of Science - SPECIALIZATION, BIOLOGY
CONCORDIA UNIVERSITY
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