Justin Wall
TMF Quality Project Manager @ IQVIA Biotech
Cary,North Carolina
Summary
Accomplished TMF Quality Project Manager at IQVIA Biotech, leveraging expertise in eTMF platforms. Oversight of eTMF file reviews on studies across many therapeutic indications and eTMF platforms. Excel in client communication and records management, facilitating seamless project execution. Successfully trained teams on eTMF platforms and workflows. Participate in Client Alignment Meetings, Kick-Off Meetings, and Audits as the eTMF Functional Lead on assigned studies.
Overview
10
10
years of professional experience
Work History
TMF Quality Project Manager
IQVIA Biotech
09.2023 - Current
- Facilitates communication between Records Management and user departments regarding Trial Master files.
- Applies Records Management expertise to assist with complex, multi-site projects and teams.
- Monitors daily project outputs to ensure adherence to deadlines, commitments, and goals.
- Ensures compliance with SOPs, policies, good clinical practices, and regulatory requirements for quality and timeliness.
- Acts as the primary contact for the internal project team and external clients to address inquiries and issues regarding eTMF.
- Coordinates transfer of closed studies to final destinations within agreed timelines.
- Provides study budget review and monthly EAC (estimate at completion).
- Mentor to my team as an SME for Client Alignment Presentations and Kick-Off Meetings.
- Subject Matter expert for eTMF Client Audits and Qualification/Re-Qualification Audits.
Site File Specialist I
IQVIA Biotech
01.2021 - 09.2023
- Reviewed documents from sites, IRBs, and CRAs to ensure GCP compliance and adherence to IQVIA Biotech SOPs throughout start-up, maintenance, and close-out phases.
- Submitted study level continuing reviews to central IRBs.
- Conducted periodic site file reviews on assigned projects to ensure compliance with GCP and IQVIA Biotech SOPs.
- Distributed and tracked protocol amendments and IRB approvals, as required during the study.
- Distributed and tracked SUSAR/DSUR safety reports to sites.
- Maintained accurate tracking of site-specific ICF templates, and completed ICF checklists throughout the study.
- Negotiated ICFs on behalf of IQVIA Biotech between the Client and the Site.
Site File Operations Administrator
IQVIA Biotech
11.2019 - 01.2021
- Ensured quality and regulatory compliance of Investigator Site Files during study maintenance periods.
- Conducted ad hoc pre-RMV and pre-COV Site File Reviews to uphold standards.
- Opened, tracked, and resolved action items for sites across multiple studies in CTMS.
Site Identification Specialist
PSI CRO
06.2018 - 09.2018
- Identified Principal Investigators for global trials in oncology, medical devices, and rare disease indications.
- Conducted outreach via email, phone, and fax to assess interest from principal investigators.
Site Identification Administrator
IQVIA Biotech
05.2016 - 05.2018
- Identify principal investigators at clinical trial sites and generate site lists for post-Award global studies that fulfill RFP and protocol specifications.
Education
Associates Degree - Biological Sciences
Wake Technical Community College
United States01.2019
Certificate - Emergency Medical Technician
Wake Technical Community College
United States12.2010
Skills
- eTMF platforms SME (Veeva Vault, Wingspan, Trial Interactive)
- TMF plan development
- Regulatory compliance
- Quality assurance
- Document review
- Client communication
- Site communication
- Client alignment meetings and kick-off meetings
- Client audits
- Study budget review
Timeline
TMF Quality Project Manager
IQVIA Biotech
09.2023 - Current
Site File Specialist I
IQVIA Biotech
01.2021 - 09.2023
Site File Operations Administrator
IQVIA Biotech
11.2019 - 01.2021
Site Identification Specialist
PSI CRO
06.2018 - 09.2018
Site Identification Administrator
IQVIA Biotech
05.2016 - 05.2018
Associates Degree - Biological Sciences
Wake Technical Community College
Certificate - Emergency Medical Technician
Wake Technical Community College