June Wright
Franklinton,NC
Summary
Clinical research and operations leader with deep experience in global trial management, study start-up, vendor oversight, and contract administration across pharmaceutical, biotechnology, and CRO settings. Leads risk-based monitoring, site communication, and data review to support patient safety, GCP compliance, and timely study delivery. Seeking a product safety lead role supporting lifecycle safety and pharmacovigilance.
Overview
21
21
years of professional experience
Work History
Sr. Global Clinical Trial Manager
IQVIA CRO
07.2019 - 01.2025
- Work with the study startup, budget & contract team & feasibility team to select sites and review feasibility questionnaires.
- Tweak questionnaires according to the protocol design
- Manage and execute contracts, including Master Service Agreements (MSAs), Statement of Work (SOW), Confidentiality Disclosure Agreements (CDAs), etc., and amendments to site and vendor agreements.
- Vendor Management
- Purchase orders
- Risk Base Centralized Monitoring, centralized monitoring.
- As Sr. Global Lead Sr. CTM with oversight of the centralized monitoring team review data to ensure data clean at all study levels, site level subject level. Identifying, investigating, managing, confirming, and reporting key risk indicators, at all levels.
- Subject Level Data Review/Remote Review/Central Data Review
- Listings Review/Patient Profile Review
- Query Generation and Management
- Support Risk Base Monitoring support.
- Review of Key Risk Indicators through visualizations/data review panels/outlier report
- Risk Base Monitor - Key Risk Indicators (KRI)
- Subject level
- Safety – AE’s; SAEs; Subject level SAEs
- Query – High query rate; Query aging; Answered query aging.
- Focused data review based on Key Risk areas for RBM Studies
- Site Communication & Management
- Routine Site Communication
- RBM and Quality: Critical to Quality (C+Q)
- Quality + patient safety; QTLs define when those critical elements are at risk
- Triggered Site Contact due to Risk Threshold
- Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work documented within contracted project scope. Communicate and document all interactions with clients as required by SOP.
- Serve as client advocate within IQVIA Biotech.
- Develop and implement Clinical Monitoring Plan.
- Attend and provide information at weekly client teleconferences/team meetings.
- Assist the Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.
- Manage CRA performance: Review monitor reports, review and pay invoices against budget.
- Prepare sites, CRA for inspections (training)
- Define and implement functional standards, goals, and expectations with clinical monitoring team.
- Serve as CRA mentor and perform accompanied field assessment visits as required.
- Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
- Assure that the appropriate IQVIA Biotech and/or sponsor SOPs followed.
- Ensure all project documentation appropriately filed per IQVIA Biotech SOPs.
- Assist PM in preparation of audit responses, as appropriate.
- Assist PM with preparation of information for inclusion in the monthly report to client.
- Assist PM in review of project budgets, monitoring costs, potential propose/ implement cost effective solutions.
- Define the scope of work with the client and clinical monitoring team.
- Assist PM in identifying and generating changes in scope and notify clients of potential changes in scope.
- Review and approve CRA travel expenses and time sheets.
- Lead CRA weekly team calls.
Associate Project Manager
TFS Health Science CRO
Princeton, NJ
12.2017 - 07.2019
- Identify, defining, document training requirements in systems and assure project level compliance with study specific training requirements.
- Responsible for change management on all assigned projects
- Responsible for assuring projects assigned are run according to SOPs and in the contract.
- Responsible for assuring project timelines are met as per contract.
- Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead.
- Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware.
- In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.
- Provide other project support to Managers, as assigned.
- Oversee delegation of support staff activities, as necessary
- Assists in the development and delivery of capability and proposal defense presentations to prospective clients.
- Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team.
- Represents senior management in negotiation of contracts as appropriate.
- Manage CRA performance: Review monitor reports, review invoices against budget.
- Manage and execute contracts, including Master Service Agreements (MSAs), Statement of Work (SOW), Confidentiality Disclosure Agreements (CDAs), etc., and amendments to site and vendor agreements.
- Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually.
- Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
- Responsible to maintain personal currency documentation per TFS SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff
Study Manager
InVentiv Health Consultant
Princeton, New Jersey
01.2016 - 12.2017
- Management of third-party vendors including CROs, and sites
- Process draft protocol concept approval for IITs studies.
- Work with drug safety and pharmacovigilance team contributing to the safety of our products.
- Collect and process adverse event reports in accordance with regulations and company policies
- Monitor and review adverse event reports
- Ensure findings is captured in the risk management plans
- Participate in quality audits and inspections as required
- Review draft protocols and ICFs until final (making sure site IRB approved)
- Review and finalize draft Protocol, ICF, Data Management Plan, Monitoring Plan
- Review queries for distribution to the sites.
- Review protocol deviations and prepare for sponsor quarterly PD meeting with safety team.
- Lead/conducted clinical trial team (CTT) meetings.
- Review site and vendor invoice(s) for payment approval.
- QC of study documents, compiled and uploaded in CTMS system(s) eTMF, and documents stored on the shared drives.
- Work with the study startup, budget & contract team & feasibility team to select sites and review feasibility questionnaires.
- Tweak questionnaires according to the protocol design
- Manage and execute contracts, including Master Service Agreements (MSAs), Statement of Work (SOW), Confidentiality Disclosure Agreements (CDAs), etc., and amendments to site and vendor agreements.
- Purchase orders
- Review invoices against contract SOW and approve payment.
- Track milestones and enter dates into CTMS.
- Review all data discrepancies from local and central lab and other vendors working on the trial such documents as (questionnaires, study diaries used on assigned study
- CTMS user access for internal and external study team members and clients
- Data review with exported data from Medidata Rave
- Performed data review, edit checks, open and close out queries.
- Review issues and action plan at the site and vendor level.
- Lead core team meetings, vendor meetings, site meetings with study coordinators and PIs.
- Maintain TMF and prepare sites for inspections.
Study Manager
Research Pharmaceutical Services Consultant
Princeton, New Jersey
10.2015 - 01.2016
- Develop, review, and finalize project plan(s), study contract and budget(s)
- Create project-related study documents including drafting of protocol, case report forms, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed.
- Create Clinical monitoring plan.
- Create risk base monitoring plan.
- Create communication plan.
- Create protocol deviation plan (coordinate PD meeting with sponsor per SOW/budget)
- Evaluate and select CROs, and vendors.
- Reconcile site and vendor invoices/budgets and authorize payments.
- Conduct Clinical Trial Team (CTT) meetings with internal and external partners.
- Work with data management in reviewing data listings.
- QC of study documents compiled and uploaded in eTMF, and documents stored on the shared drives.
- Review data management plan (review all data listings, and queries)
- Work with drug safety and pharmacovigilance team contributing to the safety of our products.
- Collect and process adverse event reports in accordance with regulations and company policies
- Monitor and review adverse event reports
- Ensure findings is captured in the risk management plans
- Participate in quality audits and inspections as required
- Review all data listings and lab reports from lab vendors.
- Work with the study startup, budget & contract team & feasibility team to select sites and review feasibility questionnaires.
- Tweak questionnaires according to the protocol design
- Manage and execute contracts, including Master Service Agreements (MSAs), Statement of Work (SOW), Confidentiality Disclosure Agreements (CDAs), etc., and amendments to site and vendor agreements.
- Track milestones and enter dates into CTMS.
- Track and review protocol deviations.
- Track and close out open action items from MVR.
- Perform data review, edit checks, open and close out queries.
- Review issues and action plan at the site and vendor level.
- Lead core team meetings, vendor meetings, site meetings with study coordinators and PIs.
Regulatory Affairs
Bridgewater, New Jersey
09.2013 - 10.2015
- Review advertisements
- Responsible for reviewing, approving, and ensuring compliance of advertising and promotional (ADPROMO) materials with applicable regulatory requirements, industry standards, and internal policies.
- Act as a key liaison between marketing, legal, medical, and regulatory teams to support compliant product promotion
- Tracked regulatory updates and assessed impact on promotional practices.
- Supported responses to regulatory inquiries or enforcement actions related to advertising and promotion.
- Filed all AD’s in the archival room accordingly.
- Aventis / Sanofi Pharmaceutical
Clinical Trial Manager
Bridgewater, New Jersey
08.2003 - 09.2013
- Coordinate, review and compile study specific study documents from study startup, site selection, country selection and managed study projects to study closure.
- Coordinate, review, and compile study specific appendices for clinical study report writing.
- Collaborate with liaisons in ROW regarding regulatory regulations and timelines.
- Collect and obtain signatures for Power of Attorney and Certificate of Insurance for study countries.
- Review vendor deliverables from system generated metrics.
- Review draft protocols and ICFs until final (making sure site IRB approved)
- Review and finalize draft protocol, ICF, data management plan, monitoring plan, project management and communication plan, safety management plan.
- Review Queries for distribution to the sites, and all other data listings.
- Collaboration with procurement with vendor contracts, purchase orders
- Manage CRA performance: Review monitor reports, review invoices against budget.
- Manage and execute contracts, including Master Service Agreements (MSAs), Statement of Work (SOW), Confidentiality Disclosure Agreements (CDAs), etc., and amendments to site and vendor agreements.
- Work with finance with study and vendor contract; receive invoices and approve payments to third party vendors and study sites.
- Distribute study site regulatory documents, track documents and green light sites for study start sites.
- Study start-up, site selection to study closure (coordinating, reviewing study documents, and study appendices for Clinical Study report
- Responsible for site feasibility and pre-trial site assessment visits
- Close out action and issues at sites, and vendor level
- Responsible for executing activities during site initiation and startup site.
- Global vendor management
- IMP supply management
- Review protocol deviations with CRAs for resolution.
- Ensure all study documents filed in the TMF/eTMF.
- Responsible for assuring the needs of clinical sites are met by facilitating clinical monitoring processes, including:
- Coordinate site management activities.
- Site identification, recruitment, and selection.
- Regulatory document collection and review.
- Overall scheduling and management of all site visits.
- Develop site/monitoring tools and training materials.
- Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
- Coordinate and oversee daily operations of clinical monitoring team:
- Set and enforce project timelines with the assigned study team.
- Coordinate remote review of clinical data within EDC system.
- Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
- Review and approve trip reports and follow-up letters within the required period.
- Schedule and manage weekly CRA project team meetings.
- Ensure CRAs assigned to team receive therapeutic and project-specific training.
- Manage quality and regulatory compliance among clinical monitoring teams and investigational sites.
- Manage project milestones and proactively address deficiencies:
- Attend and provide information at monthly projections meetings.
- Create Clinical monitoring plan and risk base monitoring plan.
- Create protocol deviation plan (coordinate PD meeting with sponsor per SOW/budget)
- Review data management plan (review all data listings, and queries)
- Work with drug safety and pharmacovigilance team contributing to the safety of our products.
- Collect and process adverse event reports in accordance with regulations and company policies
- Monitor and review adverse event reports
- Ensure findings is captured in the risk management plans
- Participate in quality audits and inspections as required
- Review all data listings and lab reports from lab vendors.
- Aventis / Sanofi Pharmaceutical
Education
MBA / Bachelor of Science / Master of Business - Health Administration
01-2009
Skills
- GCP training
- Subject confidentiality / HIPPA
- Investigation support / Academic institution
- Patient education
Custom Section 1
My professional background has provided me with a well-rounded perspective at the intersection of Health Science, Business, and Information Technology, allowing me to understand how these disciplines work together in today’s evolving healthcare and business environments. With more than 20 years of experience in healthcare and clinical research, including extensive leadership of global clinical trials, I have worked across clinical operations, business strategy, project management, regulatory compliance, quality, data, technology, vendor management, and cross-functional collaboration. My MBA further strengthened my understanding of business operations, leadership, financial and contractual considerations, and process improvement, while my healthcare experience has given me firsthand insight into how technology and data support patient care, clinical research, decision-making, and innovation. I am passionate about bringing this interdisciplinary perspective into the classroom and helping students understand that Health Science, Business, and Information Technology are not separate worlds—they are interconnected areas that prepare students for the rapidly changing workforce and the many career opportunities available across healthcare and business.
Timeline
Sr. Global Clinical Trial Manager
IQVIA CRO
07.2019 - 01.2025
Associate Project Manager
TFS Health Science CRO
12.2017 - 07.2019
Study Manager
InVentiv Health Consultant
01.2016 - 12.2017
Study Manager
Research Pharmaceutical Services Consultant
10.2015 - 01.2016
Regulatory Affairs
09.2013 - 10.2015
Clinical Trial Manager
08.2003 - 09.2013