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Start-Up Operations ￨ Project Management ￨ Site Management ￨ Process Development / Implementation
Relationship Development ￨ Trends Tracking ￨ Strategic Analysis / Planning ￨ Regulatory Intelligexxxxxxe
Risk Assessment / Management ￨ Corrective Action Plans ￨ Short- / Long-Term Planning ￨ Client Relations
Business Model Development ￨ Regulatory Compliaxxxxxxe ￨ SOP ￨ SOW ￨ WI ￨ Negotiations ￨ Account Oversight
- Dynamic Leader who offers a background in driving business operations and growth, developing forward-thinking initiatives, and providing award-winning customer service, and exhibits an ability to see the big picture within diverse industries and fields while developing new business models for unique and innovative employers.
- Enterprising Top Performer who boasts above-average career results, and can make sound decisions to reflect positively on operations in alignment with a company s vision, value, and goals to achieve a significant advantage.
- Excellent Communicator who builds and sustains synergistic relationships with C-level executives, business / operational teams, and clients, and can successfully assess and resolve complex challenges while ixxxxxxreasing efficiexxxxxxy, improving business processes, reducing costs, and leading staff by example and with ethics and integrity.
- Ambitious Self-Starter who has spearheaded new processes to strengthen business, and is passionate about providing award-winning business partnerships and alliaxxxxxxes to promote truly exceptional customer experiexxxxxxes.
Site Management Project Coordinator (2012 Present)
Capitalize on the opportunity to manage the delivery of required start-up, maintenaxxxxxxe, and regulatory activities for selected studies as determined by the sponsor s Scope of Work and contract terms, ixxxxxxluding developing, implementing, and maintaining Site Management Study Plan per Scope of Work and Project Plans per strategies.
Ensure accurate completion and maintenaxxxxxxe of internal system databases, tracking tools, timelines and project plans, and further work with accounts at multiple levels to maximize understanding and influexxxxxxe over decision-making.
Build and sustain mutually beneficial relationships with key members of operational study and management teams.
Successfully led development of new processes, i.e. S.M.A.R.T system, to achieve goals.
Converted new and repeat business while managing companywide mission and key vision.
Created data-driven tools and processes for a fully integrated operational technology platform.
Developed new processes to assist with study compliaxxxxxxe to ensure project milestones were met.
Aligned ixxxxxxentives to focus on what truly matters to customers and drive business to create revenue.
Created new initiatives to achieve faster start-up timelines, improve investigator contracting timelines, and where studies have been able to enroll more patients per site and per month, ixxxxxxluding using The Right Path and The Right Start strategies to leverage streamlined and optimized processes, interactive regulatory tools, and new efforts using real-time leading measures.
Recognized for job performaxxxxxxe excellexxxxxxe with numerous awards for Outstanding Customer Service and dynamic, innovative ways to streamline processes that has helped to grow the business.
Site Start-Up Specialist ￨ Associate Start-Up Team Lead (2009 2012)
Utilized broad scope of industry knowledge and dynamic business acumen toward managing the delivery of required start-up, maintenaxxxxxxe, and regulatory activities for selected studies as determined by sponsor s requirements, ixxxxxxluding managing pre-award activities and oversight of the scope of work, budgets, and resources.
Led targeted facilitation of contract negotiations and reached closure and execution of new business opportunities.
Site Start-Up Specialist ￨ Associate Start-Up Team Lead (2009 2012) (continued)
Monitored team efficiexxxxxxy and adherexxxxxxe to project timelines.
Served as Site Start-Up Lead within country / region projects or service lines.
Ensured adherexxxxxxe to SOPs, Work Instructions (WIs), and quality of designated deliverables.
Spearheaded results-focused communications between internal business and legal professionals (e.g. general counsel, proposals and grants analysts, and project managers) and external parties (e.g. sponsor project management, research and academic institutions, prixxxxxxipal investigators, outside counsel, and vendors) to meet goals.
Expertly guided contract management fuxxxxxxtions that advaxxxxxxed projects, ixxxxxxluding maintaining and providing comprehensive status reports and working directly with Contract Managers to consistently realize project goals.
Reviewed and negotiated site regulatory documents and contacts with key sites and sponsors.
Successfully led SSU data tracking entries in database and review for completeness and accuracy.
Site Start-Up Specialist
Strategically steered communications between internal business and legal professionals (e.g. general counsel, contract managers, proposals and grants analysts, project managers, research associate) and external parties (e.g. sponsor project management, research / academic institutions, prixxxxxxipal investigations, outside counsel, vendors).
Successfully advaxxxxxxed projects, ixxxxxxluding facilitating negotiations and maintaining status reports.
Coordinated direct efforts with contract managers to ensure consistent realization of project goals.
Youth & Adult Services Case Manager
Played a vital role in developing and implementing individualized pre-trial plans and ensured defendants complied with court-ordered conditions, ixxxxxxluding curfews, weekly office visits, and showing up for scheduled court dates.
Ensured clients were engaged in productive activities to develop effective problem-solving and life strategies.
Led psycho-education groups on issues (e.g. anger management, job hunting, and drug awareness).
Bachelor of Arts in Liberal Arts (Behavioral Psychology & Criminal Justice Emphasis, Magna Cum Laude Honors)
Clinical Trial Management Systems ￨ Quintiles Infosario ￨ Clinical Informatics
Spotfire ￨ IntraLinks ￨ eTMF ￨ Microsoft Office ￨ Microsoft SharePoint ￨ ELVIS
Excellent Professional Referexxxxxxes & Professional Publications Provided Upon Request
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