Michelle Harris
Sr. Project Specialist
Placentia,CA
Summary
Adaptable professional with a quick-learning ability and a talent for adjusting to new environments. Skilled in rapidly acquiring new knowledge and applying it effectively. Driven by a passion for continuous learning and successfully navigating change. Strong proactive problem-solving abilities and a proven track record of fostering strong relationships with clients and team members. Focused on supporting team success and achieving positive results.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Sr. Project Specialist
Syneos Health
01.2022 - 08.2024
- End-to-end project coordination support to Project Manager and Cross Functional Leads, adhering to project and organizational standards.
- Acted as lead in absence of PM on both internal and external meetings.
- Ran financial variance and compliance checks through different systems for weekly, monthly and quarterly management and client meetings.
- Conducted protocol deviation meetings with study team and client; included a dashboard noting any trends that lead to protocol revisions or interventions at sites.
- Oversaw study risk management, conducted risk review meetings, and established mitigation plans as needed.
- Main point of contact for IRB submissions, renewals, and closures, study budget, investigator payments, study dashboard and trackers.
- Developed study management plans with limited oversite from Program Manager.
- Managed all e-learning for multiple studies, conducted compliance checks and reported on any overdue/incompleteness.
- Acted as study on-boarding specialist.
- Provided mentorship to new project specialist throughout the company, offering guidance on navigating systems as well as tools and tricks to help with efficiency and automation when possible.
Clinical Project Coordinator III
Medtronic
02.2018 - 12.2021
- Manage updates to clinical study budget, training assignments, and other project management workstreams as needed.
- Assist study team with ongoing trial management activities.
- Perform a wide variety of non-routine administrative tasks and support special project needs.
- Create reports and dashboards from data exports.
- Oversaw management of the eTMF for numerous studies.
- Met with device specialists in R&D to develop the study specific Device Management Plan with limited oversite from study manager.
- Subject Matter Expert for Device Management, Investigator Payments, CTMS, e-TMF, e-Learning, and IRB Submissions.
Administrative Assistant III
Medtronic
12.2015 - 10.2018
- Direct assistant to Senior Director, Program Manager, Medical Science Liaisons, and Clinical Education Specialists; manage calendars, travel, and credit card allocations for our team of 8.
- Spearheaded coordination of medical education programs, showcasing adeptness in event planning and execution.
- Oversaw department budget management and expenses; ensuring department expenditure aligned with budgetary constraints; created extensive department trackers and dashboards for monthly finance meetings which resulted in a 20% reduction in excess program spending.
- Subject Matter Expert in Sunshine Act Reporting for the entire division (Physician Education, Clinical, Marketing, R&D, and Sales Training).
- Negotiated purchase of medical training modules and supplies.
Administrative Assistant
Allergan
03.2015 - 12.2015
- Provided administrative support to the corporate occupational health nurse and coordinated inter-departmental document management tasks, including the systematic filing, archiving, copying, and secure faxing of confidential health documents.
- Efficiently scheduled employee appointments and departmental meetings, ensuring seamless operations.
- Led the organization of a companywide blood donation event, demonstrating exceptional event planning and execution skills.
- Managed the procurement of medical and office supplies, optimizing inventory levels and resource utilization.
- Conducted thorough reviews and revisions of departmental procedures, enhancing operational efficiency.
- Processed and coded invoices using SAP and facilitated the routing of departmental procedures and policies for signature and approval, ensuring compliance and timely execution. Initiated the creation of new employee medical files and implemented a reminder system for vaccine renewals, contributing to employee health management.
- Crafted and delivered written responses to routine inquiries, maintaining high standards of communication.
- Developed and refined reports, memos, and emails, improving document quality and accessibility.
Skills
- Program Management
- Agile
- Scrum
- Budget Management
- Financial Variance
- Plan Development
- Scheduling
- Document Control
- Regulatory Compliance
- MondayCom
- Asana
- SmartSheets
- Dashboards & Metrics
- Key Performance Indicators (KPI)
- SAP
- Advanced user in Microsoft Office
- Google Suites
- Excel
- Word
- PowerPoint
- SharePoint
- Access
- Project
- Teams
- PowerBI
- GoogleDocs
- Clinical Tools
- Medidata CTMS
- Medidata Rave
- Veeva Vault eTMF
- E-Learning Module Set-up
- Siebel CTMS
- Project management
- Risk management
- Clinical research
- Budget management
- Regulatory compliance
- Data analysis
- Dashboard creation
- Training development
- Study coordination
- Problem solving
- Effective communication
- Time management
- Documentation management
- Scope management
- Deadline driven
- Financial analysis
- Vendor management
- Gantt charts
- Analytical skills
- Agile methodology
- Attention to detail
- Resource allocation
- Asana software
- Stakeholder engagement
- Creative solutions
- Mentoring and coaching
Certification
Google Project Management, 2023
Hobbies and Interests
- Gaming
- Reading
- Traveling
- Baking
- Music
- Volunteering
- Parenting
- Hiking
- Embroidery
- Woodworking
- Animals
Timeline
Sr. Project Specialist
Syneos Health
01.2022 - 08.2024
Clinical Project Coordinator III
Medtronic
02.2018 - 12.2021
Administrative Assistant III
Medtronic
12.2015 - 10.2018
Administrative Assistant
Allergan
03.2015 - 12.2015