Luis Louie Paredes
Director Clinical R & d Project Management Includes Operations @OPKO Health, Inc.
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WORK HISTORY
Director Clinical R & d Project Management Includes Operations @OPKO Health, Inc.
Miami, FL, US
Led Clinical Pre-Post Clinical Studies Phase I-IV Launch; Includes Site identification, CROs, Vendors • Head Clinical Trials Project Management; Multifunctional Teams, Recruitment, and In-House services • Clinical Site and CRO Startup, Activation, and Going thru COV Lead; includes GCP, TMF, FUP, Organize • Head Clinical Study IP Supply and Lab Management; Sourcing, Distribution, Clinical Site Management • Led Executive Management, Study Teams and Alliance Progress and Performance Communications • Contracts; Source, Negotiations, CROs, Clinical Sites, Vendors, Internal Resources, Grants Mgr (FMV) • Led other Renal Division activities; Managing Team Priorities, Inspection Ready, Vendor Storage, CMC • Led Liaise Operations Functions; Finance, Legal, Quality, 3rd Parties, Alliance, Commercial, CEO. Establish, optimize, and govern the Clinical organization processes and operations (Phase I-IV) during design, planning, start-up, implementation and going. Work within the organizational functions to ensure full alignment to leverage best practices and knowledge. Validate synergies gained across all functions on key Clinical procedures, risk management, capabilities, and deliverables. Established routines; developing dash boards, measuring KPIs and instilling the mind set to become a learning organization. Evaluate and improve Clinical Trial deliverables such as; Recruitment, Advertising, IP and Lab Supply Management, Site and CRO sourcing, Budget Negotiations, Planning, and Utilization. Collaborate with Global partners from Medical, Clinical, Commercial, CMC, QA, Legal and Finance.
ABOUT LUIS LOUIE PAREDES
Passionate Doer, Record Breaker, Team Builder with 25+ years Proven US/International Results • Team chosen and Winner of multi-functional awards and initiatives worldwide • Effective and Innovative Executive in Supply Chain, and Clinical Project and Operations Mgmt. • Experienced in Pre-Post Clinical Trials, Medical Devices, Pharmaceuticals, Consumer Goods • Operations and Project Management Mastery in Startup/Ongoing, Lean, Program E2E Life Cycle • Expert Level in Analytical, Mapping and Simulations for Right Decisions, Metrics, Optimization I am considered enthusiastic, purpose-driven, hands-on while having well thought out problem-solving proficiency with strong interpersonal skills and ability to lead multi-discipline organizations to successful outcomes. A pro-active, creative and critical thinker with a consistent track record of business growth results based on an entrepreneurial attitude and demonstrated leadership skills across multi-functional teams, cultures, organizations and joint ventures. High performance work ethic, organized and disciplined in managing daily operations and longer term projects; always acting as a business owner to challenge status quo to drive right decision making and ask, “What’s next?” Be passionate, and think big, love what you do and always believe in the team and you. Let\'s find cures and STOP the hurt. Favorite Quotes: Roger Federer: Staying the same is going backward. Mine: Organization is the key to efficiency. Mine: The moment someone asks you a question, that person instantly becomes your customer.dazzle them. Therapeutic Areas ONC (Oncology) RESP (Respiratory) CNS (Central Nervous System), Pain, Addiction WHC (Women’s Health) CVM (Congenital Vascular Malformation) MS (Multiple sclerosis), Pallative Care ESRD (Renal) CKD 3-5 Nephrology Hematology PC (Primary Care) Neuropsych, Neurodegen Rare Disease Interests Culture>Strategy, Big/Smart Data, Digital Disruption, Lean, Cures, Life Science, TEAM
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