Melanie Nobello
Summary
Experienced operations leader with 15+ years of success in optimizing processes and driving efficiency within complex organizational structures. Skilled in managing large-scale projects, leading cross-functional teams, and implementing innovative solutions to enhance operational effectiveness.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Freelance Consultant
Independent / Contractor
12.2023 - Current
- Operations and administrative management support inclusive of production, quality control, and financial and data management projects for small businesses within varied industries across the SF Bay Area.
Director/Manager, Clinical Research Office
Sutter Health, Office of the Chief Research and Health Equity Officer
Sacramento, CA
06.2015 - 01.2023
- Designed and Established Central Office: Played a key role in designing and establishing a new central research office, optimizing job roles and talent to foster collaboration, improve workflow efficiency, and enhance operational effectiveness throughout Sutter Health's operations in Northern California.
- Built and Managed High-Performing Remote Teams: Recruited, trained, and led a team of 15+ new and veteran clinical research professionals, fostering a collaborative and efficient work environment.
- Implemented Clinical Trial Management System (CTMS): Led the selection and implementation of a new CTMS for the new central office, improving data management, trial tracking (inclusive of patient accruals and study financials), and overall operational efficiency for over 350 clinical trials.
- Streamlined Operational Processes: Implemented innovative, continued process improvements to support initial reduction of start-up days by 10%, enhancing team productivity, and ensuring front-to-backend research billing compliance.
Manager, Research Operations
Research and Education Institute (REDI), Alta Bates Summit Medical Center
Berkeley, CA
03.2012 - 10.2013
- Managed day-to-day operations for REDI research including Continuing Medical Education (CME) for multiple campuses.
- Advanced clinical trial protocols, contracts, grants, budgets, and regulatory documents for Principal Investigators.
- Led multi-disciplinary, cross-functional study execution teams from feasibility to study close.
- Reviewed, edited and negotiated contract terms with industry sponsors, vendors, physicians, medical groups and other REDI business partners.
- Ensured timely, on budget internal and external deliverables through on-going collaboration across functional areas.
- Coproduced and implemented marketing strategies, physician engagement efforts, and performance goals.
- Enhanced standard operating procedures and processes improving department efficiencies.
Research Financial Specialist (Analyst)
Research and Education Institute (REDI), Alta Bates Summit Medical Center
Berkeley, CA
09.2007 - 03.2012
- Developed and negotiated study budgets with sponsors; managed study financials including A/R, A/P, invoicing, milestone revenue and physician reimbursements.
- Sourced and managed relationships of REDI vendors and partners to meet study protocol requirements.
- Super-User/Trainer and database administrative manager for CTMS.
- Collaborated with CPA and assisted with month end, quarter end, and annual financial close according to GAAP.
- Delivered projections, financial, and ad-hoc reports with trend and data analysis to support operational and financial decisions.
- Ensured adherence and compliance of federal and state regulatory requirements related to HIPAA, Medicare qualifying clinical trial checklist, and clinical research billing.
Education
Bachelor of Arts in Business Management -
Holy Names University
Oakland, CASkills
- Operations and Financial Management
- Partner and Vendor Relationship Management
- Compliance and Quality Assurance
- Team Leadership
- Project Management
- Process Improvement
- Systems Implementation
- Contract Negotiation
- Data and Financial Analysis
- MS Office/Access
- Google Docs
- Salesforce
- PeopleSoft
- EPIC EMR
- CTMS (Pre & Post Award/Grant Management)
- Workday
- MediTract
- Lawson
Certification
- Certificate in Healthcare Research Compliance | Health Care Compliance Association
- Certificate in Financial Management for Business Decisions | Cornell University
Timeline
Freelance Consultant
Independent / Contractor
12.2023 - Current
Director/Manager, Clinical Research Office
Sutter Health, Office of the Chief Research and Health Equity Officer
06.2015 - 01.2023
Manager, Research Operations
Research and Education Institute (REDI), Alta Bates Summit Medical Center
03.2012 - 10.2013
Research Financial Specialist (Analyst)
Research and Education Institute (REDI), Alta Bates Summit Medical Center
09.2007 - 03.2012
Bachelor of Arts in Business Management -
Holy Names University