Lee Barsky, Mha_Mba, Pmp Email and Phone Number
Philadelphia, PA, US
Lee Barsky, Mha_Mba, Pmp's Location
Greater Philadelphia, United States, United States
Lee Barsky, Mha_Mba, Pmp's Contact Details
Lee Barsky, Mha_Mba, Pmp work email
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About Lee Barsky, Mha_Mba, Pmp
Senior Level Drug Development Professional with over 25 years of diversified Clinical Research Operations Strategy, Set-up and Hands-on-Execution Experience including: Corporate Leadership, Revenue Generation paired with Business Development Leadership achieving unprecedented Results.Business Development/Contracts and Proposals/Outsourcing 15+ years of Proven Sales and Procurement experience in Pharma/Biotech, CROs and Third-Party Suppliers. Most recently, responsible for Global Sales, Marketing and Proposals at ACL Digital Life Sciences focusing on Data, Biostats, Programming, Technical Writing, Regulatory Affairs, QA, Pharmacovigilance and Staffing Services. Sold and managed in excess of 300 Million in Services- exceeding targets and expectations with a close-the-deal mentality.Clinical Operations/Clinical Research20+ years of Hands-on Project/Program Operations and Leadership experience conducting over 2,000 clinical trials in a diverse spectrum of therapeutic areas. 15 years of Focused Early Phase clinical development running and managing Several Phase 1 organizations along with extensive experience in Late Phase research as well from both the Pharma and CRO side of the business. QMSOver 15 years of Hands on QMS Support, Development and Auditing Experience. Created foundational SOPs for 3 different organizations. Supported and Performed Various types of Audits both Sponsor and Vendor, Internal and External. Represented organizations as the QMS representative, Operations Lead and Executive Leadership. Extensive FDA Audit and PMDA Audit Experience from both the Pharma and CRO side of the business. General OverviewMy Moto is: Exceed Expectations always, Create Trust and Deliver on Promises.The Measurable and Sustainable Value I bring to an organization is: -The Ability to Analyze and Build on Existing Relationships and Operations - Engage Staff while Implementing Strategies and Processes to Improve Productivity and Efficiency, while Reducing Costs and Increasing Revenue. - Extensive Experience across all sides of the industryI am a Strategic Thinker and Innovator with an Impressive Track Record in Project Award and Delivery.- Over 400 Endorsements from Clients, Colleagues, and Co-Workers- Built 3 organizations from the ground up- 6 Industry Awards- including the Best CRO Award 3 years in a row
Lee Barsky, Mha_Mba, Pmp Work Experience Details
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Commercial Strategy Officer - FractionalYeza.AiPhiladelphia, Pa, Us -
Commercial Strategy OfficerInference Inc Apr 2024 - PresentChesterbrook, Pennsylvania, UsAs the Head of Sales and Corporate Strategy my role is provide controlled corporate growth and spread the word about how Biostats can impact research. Inference’s Goal is to turn data into information and information into insight. As a full-service BDMO (Biostatistics & Data Management Organization), we understand the impact experienced biostatisticians, data managers, and programmers can have on a study and offer flexible malleable solutions that make our success your success. -
Executive Industry Advisor For Clinical Operations And Business Development: Principal OwnerLab Advantage Jul 2008 - PresentStrategy Advisor for Business Development and Sales Operations - currently supporting multiple organizations in a Strategic Advisory Role on a Contractual Basis.LAB Advantage focuses on technology and consulting services for the clinical research industry. Providing world-class consulting and strategic solutions for Clinical Data Management, Biostatistics, Medical Writing, Project Mgt as well as Safety Reporting and Pharmacovigilance using cutting edge Technology and staffing solutions. I am the founder and responsible for the Overall Operations, P& L, Project Delivery and Customer Experience. Offerings include:Electronic Data Capture (EDC)Clinical Trial Management Systems (CTMS)Safety SolutionsAnalyticseProIWRSSupply ManagementMobile Applications & Integration -
Sr. Client Partner - Head Of Global Sales, Life SciencesAcl Digital Sep 2022 - Mar 2024San Jose, California, UsResponsible for Global Sales Team as well as being an individual contributor. Acquiring new Logos, Marketing the Life Science Brand, Building the BU and ensuring Successful project delivery. -
Vice President Of Global Business Development And MarketingSpaulding Clinical Research, Llc Mar 2021 - Aug 2022West Bend, Wi, UsResponsible for Highest Sales Volume in 15-year company history. Exceeded year-end goals by 3 million dollars. Rebranded company Website -Increased RFPs and repeat Business by close to 40%. Won a 5-year award with a10 Pharma Company. -
Pre-Clinical And Phase 1 Clinical Pharmacology OperationsAcadia Pharmaceuticals Inc. May 2019 - Jan 2021San Diego, California, UsLead, Managed and Directed all Pre-Clinical and Phase 1 Operations for a mid-sized bio-pharmaceutical company, including Drug Supply operations and distribution for various compounds. Responsible for all Early Phase Activities-Study Design through delivery, including all vendor activity. 14 studies in total. -
Vice President, Clinical Operations And Business DevelopmentPrc Clinical Jul 2018 - Apr 2019South San Francisco, California, UsResponsible for the day-to-day management, structure, and Operations for a US Based Contract Research Organization (CRO) supporting early phase clinical development for biopharmaceutical and device development Companies focusing on Gene Therapy, Ophthalmology, Infectious disease and CNS. Also, expanded PRC’s service offering providing management of - Quality Assurance, Data Management, Project Management, Clinical Site Monitoring, Statistics and Medical Writing services for local and/or multinational Phase I to IV clinical studies for small to midsize pharmaceutical and biotechnology companies. Developed strategic alliances with Vendors (i.e. Labs, IRBs, and IVRS) and promoting PRC’s services externally to the marketplace. Created, Reviewed Updated SOPs as necessary and Managed Business Development Team, sales goals, and revenue. Reviewed written proposals, contracts and managed corporate P&L. • Responsible for all Contract Negotiations with Sponsors • Managed all PRC Clinical RFPs and RFIs • Implemented all Vendor sub-contracts which included Master Service Agreements and Study Specific Work Orders -
Executive Advisor For Client And Project OperationsAltasciences Jan 2018 - Jul 2018Laval, Quebec, Ca -
Vice President, Clinical Operations, Business Development And Executive Team LeadershipWcct Global | An Altasciences Company Feb 2012 - Jan 2018Cypress, UsResponsibilities included Creation of the CRO division that encompassed the day to day management, structure, and Operations of a Global Contract Research Organization (CRO) supporting early phase owned and operated inpatient units for biopharmaceutical and device development, Built WCCT’s CRO Late stage Division, that provided - Quality Assurance, Data Management, Project Management, Clinical Operations, Statistics and Medical Writing services on a contract basis for local and/or multinational Phase I to IV clinical studies for small to midsize pharmaceutical and biotechnology companies. Developed strategic alliances with Vendors (i.e. Labs, IRBs, and IVRS) and Promoted WCCT’s services externally to the marketplace. Also, Created, Reviewed and Updated SOPs.Studies and Therapeutic Areas of Expertise included:Oncology- Small Cell Lung, Metastatic Breast, Multiple Myeloma and Immuno Oncology for PSA and HER2 in solid tumors, Ophthalmology, CNS, RA, GI, and Vaccines and device studies. Phase 1 inpatient and Healthy Normals (owned 2 units) through Phase 4. • Lead and supported position of Leader in Ethno-bridging Studies• Created a Vaccine Challenge Unit• Won the first BARDA funded US Vaccine Challenge TrialManaged Business Development Team of 14, managed which included sales goals, revenue, proposals and contracts and corporate P&L.• Grew the company from less than 20 million to 74+ Million.• Created a 300 Million+ pipeline -
Vp, Cro Services - Formerly AccelovanceLinical Nov 2008 - Feb 2012Osaka, JpCreated, implemented and ran the day-to-day management, structure, and overall direction for a privately held Global Vaccine focused CRO of 120+ employees providing - Quality Assurance, Data Management, Project Management, Clinical Operations, Statistics and Medical Writing services on a contract basis for local and/or multinational Phase I to IV clinical studies for small to midsize pharmaceutical and biotechnology companies. Developed strategic alliances with Vendors (i.e. Labs, IRBs, and IVRS) and promoted Accelovance’s services externally to the marketplace. Created, Reviewed and Updated SOPs as necessary. Studies and Therapeutic Areas of Expertise included:Multiple Phase I first in Man for new and novel technologies in Vaccines and other therapeutic areas Numerous Phase II/III studies in Infectious Disease, Hepatitis, Influenza, and Nutraceuticals Multiple Phase IV post marking studies• Accelovance under my direction was named best CRO within the Vaccine community in 2009, 2010 and 2011.Supported all Business Development activities including all proposals, contracts and bid defenses.• Grew the organization from less than 1 million to 25+ million. -
Sr. Mgt Consultant - Clinical Purchasing: Lab AdvantageSanofi-Aventis Jul 2008 - Nov 2008Paris, France, Fr -
Director, Clinical Operations - Sr. Mgt Consultant : Lab AdvantageDsp Clinical Research Jul 2008 - Nov 2008Montclair, New Jersey, Us -
Director, Project Management - Formerly Bio-ImagingClario Dec 2006 - Jul 2008Philadelphia, Pennsylvania, UsLead Direct and Manage a large Global Imaging CRO’s Project Management Department consisting of approx. 35 Project Managers and Project Assistants. Balancing workload of +/- 250 projects. Monitored timelines, deliverables and budgets. Coached and counseled staff, communicated expectations both internal and external, responsible for staffing plans, updating and reviewing SOP's and supporting all Business Development activities.Clinical trials centered around: Quantitative Coronary Angiography (QCA), Quantitative Vascular Angiography (QVA), CT, Angiography (CTA), Lung Density/Volume, Quantitative Computed Tomography (QCT), DXA Bone Mineral Density(BMD), Body Composition, Hip Structural Analysis (HSA), MRI Angiography (MRA), Body and Neuro Cardiac Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), Nuclear Medicine, Multi-Gated Acquisition Scan (MUGA), Single Photon Emission Computed Tomography (SPECT), Whole Body OCT, PET, PET/CT, Ultrasound, Abdominal/small parts Ultrasound, Echocardiography, Intima-Media Thickness (IMT), Intravascular Ultrasound (IVUS), FMD (flow mediated dilation), Duplex, Duplex Doppler CEUS (Contrast Enhanced Ultrasound) B-Mode and M-Mode X-Ray, Mammography. -
Adirector, Na Project Management, Strategic Research And SafetyQuintiles May 2006 - Dec 2006Durham, North Carolina, UsDirected, Supervised and Managed large late phase regional / global project(s) or program teams to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget. Also responsible for Managing Staff out of Multiple Offices on the Northeast Corridor. -
Director, Project Management - Formerly Octagon Research SolutionsAccenture Oct 2004 - May 2006Dublin 2, IeInstrumental in the development of the Project Management Department - including SOP development, oversight of all project management activities within Clinical Data Operations including all budgets and department forecasting. Responsible for the coordination and delivery of all client deliverables including but not limited to Data Management, Clinical Programming, Statistics & Medical Writing in conjunction with the assigned Project Manager. Wrote Protocols in conjunction with Study Sponsor Created and Developed CRFs/e-CRFs Wrote and reviewed stat analysis plans inconjunction with Study SponsorAlso Responsible for all Clinical RFP responses supporting Business Development Activities -
Sr. Project ManagerPra International Jul 2003 - Oct 2004Raleigh, North Carolina, UsClinical Operations Project Manager, Senior level – Managing all aspects of Phase I-IV clinical trials; coordinating activities of team members across functional disciplines; serving as the primary sponsor liaison on assigned projects. Assisted in development of proposals; developed and implemented the project plan. Review of all subsequent changes and identified project milestones and key deliverables. Maintain project profitability and review customer invoices. Review and update as necessary the projected hours. Developed project-specific training plans. Developed and implemented the communications and reporting plan. Conducted weekly status reviews, Produced the monthly executive overview report. Presented at monthly/quarterly project review meetings. Adjusted resources as needed and managed customer expectations, planed and implemented post-study debriefs. Was managing the largest Oncology Trial ever awarded to PRA, indication was Colorectal Cancer. -
Sr.CraPremier Aug 2002 - Jul 2003Morrisville, Nc, UsFunction as primary representative for all clinical, site and Clinical Research Associate issues; assist with investigator recruitment; review protocols, create monitoring plans; develop and maintain tracking tools (monitoring visits, protocol deviations, patient enrollment); create on-site tools (pocket guide, source document worksheets, patient flow sheets); coordinate CRA site assignments; conduct CRA project training; review CRA reports, letters, telephone logs; assist in preparation for site audits; assist with SAE reporting issues; monitor clinical studies according to Good Clinical Practice, Food and Drug Administration Regulation and International Conference of Harmonization Guidelines; prepare for pre-study, initiation, routine and close-out monitoring visits; review Case Report Form data as compared to the source documentation for accuracy; write detailed site visit reports; function as a liaison between the site and the sponsor. -
Project Manager IiPremier Mar 2002 - Jul 2003Morrisville, Nc, UsResponsible for the efficient and effective management of Phase II-IV clinical projects. Providing project plans and timelines to the Sponsor. Identifying and evaluating enrollment/recruitment strategies and formulating action plans to ensure timelines and corporate objectives are met. Worked with the clinical and data management team members from study start up through completion–within budget, and with the highest standards of scientific integrity and patient safety. Managed 5-8 direct reports on the clinical team. Assisted Business Development with bid preparations as well as presented to prospective clients as a Premier Project Management representative.Therapeutic Knowledge: Neurology, Rheumatology, Obstetrics & Gynecology& Oncology Other responsibilities include:• Management Team Member, Providing direction and guidance to team of direct reports •Provide assistance in the development of systems and procedures for the department.
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Sr. Management ConsultantSolutions Jul 1998 - Mar 2002Chadds Ford, Pa, Us1/2001 - 3/2002 Astra Zeneca, GILeader of the cross-functional Project Team for a Mega Branded product nearing patient expiration and facing generic competition 2/2000 - 12/2000 SmithKline, IR Purchasing Center of ExpertiseDiverse responsibilities included Project Direction and Leadership in the areas of Global Software Acquisition & Licensing, Desktop Operations and Telecommunications. 3/1999 - 2/2000 SmithKline -WSO, PurchasingDeveloped, Executed and delivered a highly visible Technology Project. Assumed responsibility for all of NA, Mexico & Brazil, managing Total Supply Chain & Providing direction and support to all the critical manufacturing sites. 7/1998 - 3/1999 SmithKline IRNA, Lead Contract SpecialistSelected to Lead the CMPO. Documents included but were not limited to Master Agreements, SOWs, SLAs, and LAs for Software Escrow, Telecommunications equipment and services, Hardware acquisition, Data Warehouse services, and Help Desk services. -
Senior ConsultantGsk 1998 - 2001Brentford, Middlesex, Gb
Lee Barsky, Mha_Mba, Pmp Skills
Leadership
Clinical Trials
Medical Writing
Ich Gcp
Cro
Cardiology
Electronic Data Capture
Trial Management
Data Management
Neurology
Infectious Diseases
Clinical Data Management
Clinical Research
Business Development
Biotechnology
Regulatory Affairs
Immunology
Standard Operating Procedure
Life Sciences
Clinical Trial Management System
U.s. Food And Drug Administration
Good Clinical Practice
Medical Devices
Quality Assurance
Strategic Planning
Strategy
Pharmacovigilance
Cro Management
Protocol
Program Management
Oncology
Clinical Monitoring
Gcp
Drug Development
Cross Functional Team Leadership
Clinical Development
Pharmaceutics
Clinical Operations
Edc
Social Media Marketing
Regulatory Submissions
Vaccines
Management
Project Management
Pharmaceutical Industry
Therapeutic Areas
Fda
Sop
Biopharmaceuticals
Lee Barsky, Mha_Mba, Pmp Education Details
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Temple UniversityPolitical Science -
Almeda UniversityHealthcare Administration
Frequently Asked Questions about Lee Barsky, Mha_Mba, Pmp
What company does Lee Barsky, Mha_Mba, Pmp work for?
Lee Barsky, Mha_Mba, Pmp works for Yeza.ai
What is Lee Barsky, Mha_Mba, Pmp's role at the current company?
Lee Barsky, Mha_Mba, Pmp's current role is Commercial Strategy Officer - Fractional.
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What schools did Lee Barsky, Mha_Mba, Pmp attend?
Lee Barsky, Mha_Mba, Pmp attended Temple University, Almeda University.
What skills is Lee Barsky, Mha_Mba, Pmp known for?
Lee Barsky, Mha_Mba, Pmp has skills like Leadership, Clinical Trials, Medical Writing, Ich Gcp, Cro, Cardiology, Electronic Data Capture, Trial Management, Data Management, Neurology, Infectious Diseases, Clinical Data Management.
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