Salena Burroughs
Indianapolis,IN
Summary
Experienced clinical operations and project management professional with 7+ years of experience executing patient and site engagement strategies, supporting cross-functional and matrix teams, and delivering projects within highly regulated healthcare environments. Proven track record of project planning, execution, compliance support, training and education coordination, vendor oversight, budget forecasting, documentation, risk identification and mitigation, and stakeholder communication across pharmaceutical partnerships including Johnson & Johnson and Eli Lilly.
Overview
10
10
years of professional experience
Work History
Project Manager – Patient & Site Engagement
ICON Strategic Solutions – Johnson & Johnson (Sponsor)
11.2021 - Current
- Translate project and study experiences into documented standards, best practices, and training-ready materials for long-term sustainability.
- Ensure accuracy and oversight of scope of work for service providers' planned services and budgets, including forecasting, financial tracking, and proactive management of PSE trial budgets and purchase orders.
- Maintain and update detailed project plans, timelines, risk logs, and budget forecasts based on the scope of work for tools, tactics, and deliverables supporting clinical trials.
- Drive execution of recruitment and retention tactics through vendor management, including review of creative and content development, global translations, material production, and technical development of applications, websites, and engagement platforms.
- Support development of patient-facing tools such as study assistance and comfort items, coordinating with cross-functional partners to reduce participation barriers.
- Coordinate reimbursement and stipend-related vendor workflows, including travel support programs, to support recruitment and retention objectives.
- Ensure compliance with Johnson & Johnson policies through documentation management, digital advertising content approvals, and submission of tools and tactics for compliance review and training alignment.
- Maintain oversight for CIRB and EC approvals as required, ensuring documentation completeness and audit readiness.
- Ensure clear communication across stakeholders including service providers, CRO partners, clinical teams, PSE teams, leadership, and compliance groups to align expectations, timelines, and training requirements.
- Contribute to study meetings via facilitation, attendance, and presenting to support education, alignment, and project execution.
- Maintain deep working knowledge of Johnson & Johnson financial, contracting, and project tracking systems including SAP and Ariba.
Senior Project Specialist – Clinical Design, Delivery & Analytics (Patient & Site Experience)
Syneos Health – Eli Lilly (Sponsor)
10.2018 - 10.2021
- Assisted with identification of and contracting with approved vendors; managed deliverables, timelines, cost tracking, and stakeholder communication.
- Reviewed accuracy of SOWs and work orders with procurement teams to ensure alignment with project scope and compliance requirements.
- Provided vendor oversight to ensure key deliverables were met; identified scope creep, risks, and supported change orders as needed.
- Created and maintained metric reports using data collected from multiple sources for delivery to clients and senior management.
- Assisted with reconciliation and identification of budget overruns; supported invoice review, approvals, and financial documentation.
- Coordinated and supported digital communication activities for internal and external engagement initiatives.
- Assisted with logistical planning of clinical trial simulations and events, both offsite and onsite, with study teams and external participants.
- Created, updated, and maintained shared information including posting monthly reports and schedules to websites, databases, and collaboration sites.
- Managed CoDESIGN activities in partnership with study teams and business partners, tracking outputs, lessons learned, and training insights.
- Coordinated selection of patient attendees by disease state with external patient recruitment vendors.
- Assisted associates with brainstorming recruitment strategies, tools, and tactics to increase diversity and inclusion in clinical trials.
- Tracked social media content and participant consents for LillyTrials and the Lilly Trial Guide website.
- Maintained documentation storage requirements to support compliance, quality standards, and audit preparedness.
- Proactively maintained daily calendars of business partners including scheduling ad hoc and recurring meetings.
- Arranged travel for key department members for customer meetings and external functions.
- Planned meetings and events of various sizes at offsite and onsite locations.
- Maintained, handled, and processed confidential information in accordance with compliance standards.
- Coordinated departmental transactions in SAP.
Senior Specialist – Clinical Design, Delivery & Analytics (Patient & Site Experience)
Diverse Staffing – Eli Lilly (Sponsor)
04.2017 - 09.2018
- Created, updated, and maintained shared information including posting monthly reports and schedules to websites, databases, and collaboration sites.
- Managed CoLAB activities with study teams, management, and business partners as needed to support project delivery.
- Created, updated, and maintained functions and permissions in SharePoint and iObeya.
- Assisted Academic Fieldwork Coordinator with management of fieldwork education programs.
- Maintained and updated databases in Excel; initiated reports for internal and external stakeholders and conducted data analysis of evaluations and surveys.
- Corresponded with coordinators and educators via email and phone; assigned placements and coordinated site reservations.
- Prepared, sent, and recorded site reservations; communicated placement information to participants.
- Ensured compliance with applicable standards and documentation requirements.
Program Assistant – Occupational Therapy Department
Indiana University School of Health Sciences
09.2015 - 04.2017
- Represented administrative staff and department on task forces and committees.
- Prepared Electronic Expense Reporting System requests and supported financial processes.
- Maintained documentation, reports, and shared information across systems and collaboration platforms.
- Ensured compliance with ACOTE fieldwork standards through documentation and coordination.
- Collaborated with administrative leadership on legal fieldwork contracts.
- Supported planning and implementation of focus groups, site visits, and continuing education events.
- Served as department receptionist with frequent interactions with students, faculty, and visitors.
- Supported faculty with administrative tasks including syllabi, exams, evaluations, and course materials.
- Booked travel arrangements for faculty, guest speakers, and interview candidates.
- Served as back-up to the Office Manager and acted as interim Office Manager for two months.
- Served on Search and Screen Committees and supported departmental events.
Education
Bachelor of Arts - General Studies, Health Education
Indiana University
05.2014
Skills
- Cross-Functional and Matrix Team Collaboration
- Project Delivery, Execution, and Lifecycle Management
- Patient Recruitment and Retention Strategy Execution
- Vendor Oversight, SOW Review, and Performance Management
- Risk Identification, Issue Management, and Mitigation Planning
- Budget and Resource Management (forecasting, purchase orders, invoice review and reconciliation)
- Stakeholder Engagement, Executive Communication, and Training Support
- Compliance and Approvals (promotional review support, IRB/EC and CIRB submissions, audit readiness)
- Systems: SAP, Ariba, Veeva Vault Clinical, Salesforce, IQVIA DrugDev
- Microsoft 365 (Excel, PowerPoint, Word, SharePoint, Teams, Outlook) and MS Project
Timeline
Project Manager – Patient & Site Engagement
ICON Strategic Solutions – Johnson & Johnson (Sponsor)
11.2021 - Current
Senior Project Specialist – Clinical Design, Delivery & Analytics (Patient & Site Experience)
Syneos Health – Eli Lilly (Sponsor)
10.2018 - 10.2021
Senior Specialist – Clinical Design, Delivery & Analytics (Patient & Site Experience)
Diverse Staffing – Eli Lilly (Sponsor)
04.2017 - 09.2018
Program Assistant – Occupational Therapy Department
Indiana University School of Health Sciences
09.2015 - 04.2017
Bachelor of Arts - General Studies, Health Education
Indiana University