Clinical trial operations & and project management with multiple complex organizations and operational matrices with numerous sites and global teams.Clinical Trial Operations Managemento Stakeholder Operations, Meetings, & Organizationo Advisor Committee Collaboration Managemento Clinical Program Managemento Study Design & Protocol Development Reviewo Regulatory Management - FDA, IRB, & Ethics Committees (US & Global)o GCP & ICH Project Plan Oversight & Adherenceo Quality Assurance & Operational Planning (SOP Development) o SOP Development & Engagement Optimization Planningo Cross-Functional Communication Initiation, Provisional Engagement, & Completion o Project Timeline Creation, Development, & Monitoringo WBS Development, Maintenance, & Supervisiono Development & Management of Project Scopes, Schedules, & Budgets o Change Impact/Risk Assessment Managemento API Sourcing (Client Partnership Liaison with Quality Agreements & Negotiations)o Drug Patent Investigationo CMC/CDMO API (DP & DPI) Project Managemento CRO/Vendor/Supplier Engagement, Negotiations, & ManagementProjects/Program(s) Managemento Trial Master File Quality Managemento Study Start-Up & Close-Out o Site Managemento Incident & AE/SAE Reporting Supervisiono Site Feasibility, Contract Negotiation, & Activationo Regulatory Document Development, Collection, & eTMF Managemento Short & Long-Term Metrics Supervisiono Study Data Management, Reporting, & Query Resolutiono Study Materials & Vendor Managemento Study Team/Site/Staff Training Developmento Staff Recruitment, Screening, & Hiringo Legal Document Review, Preparation, & Executiono Project Audits & Reportingo CRA Report Review & Managemento Study Recruitment & Enrollment Oversighto Technology Development & Systems Integrationo Complex Technical & Personnel Conflict Managemento Educational & Skill Development Directoro EDC Planning, Development, & Delivery

www.NovaGuidance.comNova Guidance specializes in providing administrative management and general management consulting services with key expertise in healthcare, personnel management, project management, community outreach, planning, development, training, marketing, and organizational strategy. With over 22 years of expertise, Erin Flannery has earned a reputation for keen planning and execution, creative collaboration, and adaptive innovation; working with small individual ventures as well as large corporate entities across industries. Nova Guidance has experience ranging from education to technology, to entertainment and health management in both the private, public and non-profit sectors. Certified SBE & DBE with Los Angeles County Transportation Authority / LA Metro (California Unified Certification Program), Metro Water District, U.S., & Port of Long Beach.Registered with Small Business Administration, U.S. government. SAM, County of Los Angeles, Bureau of Contract Administration, County of Los Angeles, & City of Los Angeles.

https://www.imdb.me/erinflanneryIMDB Bio: Erin is a SAG-AFTRA actor with an extensive and versatile background in the entertainment industry including classical and contemporary theater, film, television, voice-over, and commercial performance.Starting in the entertainment industry at the age of seven, Erin developed her skills through education and through practice; allowing her to hone in her skills in dynamic characterization, including achieving credit as key makeup and wardrobe, original content producer, and creative director for film, photography, and new media. Recently Erin has expanded her repertoire to include writing original work for a pilot, a feature, and several short form/new media productions.Erin is known best by her peers, clients, business partners, and personal relationships as an intricate and dynamic person who enjoys life and a challenge. Erin has a firm belief in walking the walk and a business and personal mantra of contribution, cultivation, and creative inspiration through the arts. Her goal is to bring a compelling performance and project execution with every project. Unimpeded by boundaries or restrictive environments, Erin always enhances the projects she works on and creates an environment that ensures positive working relationships as well as thrilled clients and audiences.

Oversaw the fulfillment of Home and Community-Based Services (HCBS) for individual members with the Arizona Department of Developmental Disabilities (DDD), the engagement of direct care and ancillary service industries for recruiting collaborations, and completed new member intake assessments enabling the agency to grow sustainably and provide quality care DDD members while meeting quality assurance standards, and successfully compliance and maintenance with DDD and DES regulatory requirements of HCBS agencies. Directly developed agency strategy for direct client needs assessment, strategic engagement of client care teams for safe client acquisition, and transition planning with individuals, families, providers, and diplomatically advocated with clients and families in crisis and disaster scenarios with governmental agencies and incident management reporting.

The Jokerr's Lair Studios (TJL Studios) is a privately owned and operated full-service music and performing arts establishment. The Jokerr is an independent artist and central character to the literary, music, performance, and entertainment storyline of The Jokerr and his “LEGACY”, in addition to providing services to the independent music industry including creative services, mixing, mastering, producing, filming, and editing.As a music and entertainment conglomerate we participate in franchise development of literary, film, music, and graphic novel industries while expanding consumer engagement, products, commodities, and distribution. The Jokerr's Lair Studios; the home and creative lair of The Jokerr himself, also provides music production, song writing, music video, editing, mixing, mastering, and artist development in the music industry. The Jokerr’s Lair Studios is known for working with other artists and producers. Our extensive list of services includes recording, video production, creative consultation, and branding for musicians including: Rhymesayers EntertainmentMagik Ninja EntertainmentEvidenceGlasses MaloneGorilla VoltageRA The Rugged ManYelawolfHopsinLauren FarrahDJ PaulAmber HunterJon ConnorMadchildIrv Da PhenomAlyssa MarieCryptic Wisdom, Whitney PeytonG-Mo SkeeNova RockafellerApollo PoetryDJ EdskiTwiztidB.o.B.Kevin GatesJoke LamboP-ThoroPennywiseMega RanDJ HoppaAlando TuckerLo Key Playboy The BeastAnno Domini Beats2Deep Beats For more information, please visit us at www.TheJokerrEntertainment.com

With extensive and a versatile background in the entertainment industry including experience in film, photography, theatre, television, fashion, image development, styling, dance, and event engagement; Beauty By Nova provides on-location artistry for hair, makeup, wardrobe, spray tanning, and many other beauty and image services.

Responsible for managing, creating, and delegating in many areas of DoMore4: Good, including the creation of a regional coalition of non-profits, businesses, leaders, celebrities, media, and educational partners who united under the common purpose of promoting kindness. Our high school programs were designed to inspire and incentivize students to perform acts of kindness, contribution, and volunteerism in a way that was fun, competitive, and educational. The technology platform was innovative in validating community service activities and facilitated legitimate community service resumes for students to use in educational and employment advancement opportunities.

Ascended from administration and support to the Founder & CEO to the Global Director of Engagement, where I oversaw eight separate entities with a focus of liaising with management and executive leadership enterprise-wide for project development, support, management, and evaluation of portfolio management and global engagement. Ensured national and international engagement strategy was developed and executed while additionally ensuring the organization was well positioned to meet our long-term objectives. Key Achievement: Spearheaded the new technology development and roll-out of the proprietary “Schools4:Good” platform to help expand and deepen the impact of our programs with Anaheim Union High School District, Miami-Dade High School District, Cleveland School District, and Los Angeles Unified School District.

Acting interim administrative, human resources, training, and general manager of a “High Quality” (HQ) gastropub, specializing in gourmet cuisine, craft beer, and craft cocktails in a luxurious lounge environment. Personally managed the recruitment, interview, hiring, and training process of a specialized staff of 83 individuals while simultaneously managing the construction, inspections, permitting, POS implementation, and back-end office/admin and payroll systems and budget management.

Worked directly with CSA Casting agents with selecting, scheduling, and auditioning talent for their film, TV, and commercial projects both union and non-union. Oversee entire daily operations including staff, 12 private auditioning studios, and location management. Maintain positive and professional relationships with both the casting directors as well as actors, who pay for the location and technology that the casting directors use. . Additionally scheduling selected talent with the cloud server and recording and uploading audition sessions through the use of CAZT proprietary software and utilities including utilization of a customized app created for iPads and iPhones for data utilization, retrieval, and communication with casting and production team leadership. Provide a healthy and happy working environment for the staff; consisting of mostly interns, to ensure low turnover rates.

University of Phoenix enrollment counselor, I conducted interviews, qualification prescreening, and managed prospective candidates through their application, financial aid, and admissions process for RN-BSN, RN-MSN, Nurse Practitioner (NP), and Health Administration bachelor and advanced degree programs. In addition, I provided skill development and support to improve meaningful outcomes with students in their degrees. Key Achievements:2012 Midwest Ambassador & Division Top Performer2011 Division DelegateFiscal Year 2010 Quarter 3 Midwest Online Outstanding Performance AwardFiscal Year 2010 Quarter 4 Midwest Calculated Risk & Outstanding Contribution AwardExecutive Management Mentoring Program Participant: Part I & IIManagement Preparation Program ParticipantAdvancement Preparation Program ParticipantKey Strategist in Elite Team Developed to address For-Profit Title IV Engagement StrategiesInspire The Fire: Employee Engagement Strategist (technology development)

Appointed as the business specialist focusing on capturing current client base managed print strategy through solution development and cost reduction strategies in their document output environments. Coordinated scanning and data capture strategies with clients for a paperless environment. A market leader with experience in a fast-paced inside/outside sales environment coordinating hardware, software, and solution based products. Organize meetings with new clients and perform assessments and sales presentations that provide clients with information about their current environments and suggested recommendations for management of their current environments which also allows for cost savings. Project managed a smooth implementation of solutions for client. • Built MPS program from the ground up • Frequently earn recognition for top sales performance • Rapidly acquired medium and large accounts locally and nationally

Through client interface and strategic partnerships, we designed, engineered, installed, and serviced luxury technology for high-end homes in Arizona through low-voltage infrastructure. Integrated systems for security, sound, lighting, and multi-media with equipment manufacturers and service providers to ensure the best solution for the home owner and highest level of customer service. Developed and fostered strategic relationships with home builders, equipment manufacturers, and interior designers.

Consultant for major accounts to optimize their voice and data infrastructure through needs assessment, design, and hardware integration. Solutions based approach to business development for businesses voice and data networks to ensure business need, goal, and fiscal requirements. • Frequently award “Top Performer” in Phoenix Market• Received Company Wide “Presidential Award” in August of 2007 for top performance nation-wide.v

Sales consultant for local Arizona based businesses around cost reduction strategies to their document production environments including archive solutions. Completed comprehensive analysis of business environment and desired outcome to achieve clientele desired results as well as maintained long-term relationships for future business.

Chain and private fine dining experience at steak house and gourmet Italian food. Additionally created training curriculum and provided instruction for new hires and staff. Managed and maintained high end bar and lounge experience for our patrons.

Achieved entry level position as Director of First Impressions, then advanced into the role of Lease Administrator working directly for the COO. Coordinate all sales lease approvals, managed Sales Force (lead management tool) as the Database Administrator. Promoted to CSR & Sales Trainer where I coordinated and conducted training on hardware and software utilization. After which my final position held with the company as a Sales Executive. Toshiba America – Six Sigma Training 2000-2003

Worked directly with voice and data providers throughout the U.S. correcting issues and data capacity on ISDN and T1 lines for video conferencing devices between physicians and pharmaceutical companies. Trained physicians on how to effectively utilize the software utility to conduct meetings with pharmaceutical representatives.