Anthony Merlino Email and Phone Number
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With over a decade of experience in Clinical Research, I have developed a comprehensive skill set that spans multiple phases of clinical trials, from study start-up to maintenance and closeout. My expertise extends beyond clinical operations, encompassing business development, regulatory affairs, and quality assurance.Clinical Expertise:Proficient in GCP and audit preparation, ensuring compliance with industry standardsExpert in TMF and Part 11 compliance, maintaining meticulous documentationAdept at project maintenance and development, driving studies to successful completionIn-depth knowledge of FDA guidelines and requirements, ensuring regulatory adherenceBusiness Development and Relationship Management:Established and maintained strong relationships with investigators, sponsors, and CRO representativesLeveraged clinical expertise to identify new business opportunities and expand research portfoliosDeveloped and implemented strategies to improve operational efficiency and cost-effectivenessContributed to proposal development and contract negotiations, securing new research partnershipsRegulatory Affairs and Quality Assurance:Ensured proper implementation and tracking of regulatory documents at clinical sitesDeveloped and maintained quality management systems to meet FDA and international standardsConducted internal audits and prepared sites for regulatory inspectionsImplemented corrective and preventive actions (CAPA) to address quality issuesProject Management and Operations:Led cross-functional teams to achieve project goals and meet TMF audit standardsDeveloped and monitored project timelines, budgets, and resource allocationImplemented process improvements to enhance study efficiency and data qualityManaged risk assessment and mitigation strategies throughout the project lifecycleCommunication and Leadership:Excellent interpersonal skills, facilitating effective collaboration with diverse stakeholdersStrong presentation and reporting abilities, translating complex clinical data for various audiencesMentored junior staff, fostering professional development and team growthContributed to strategic planning and decision-making processesThis comprehensive experience has positioned me as a valuable asset in both clinical operations and business development within the pharmaceutical and biotechnology industries. My ability to bridge the gap between scientific expertise and business acumen allows me to drive innovation, ensure compliance, and contribute to the overall growth and success of research organizations.
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Business Development ManagerKonnectmd Virtual Healthcare Apr 2023 - PresentOklahoma City, Oklahoma, Us• Built a robust opportunity pipeline through networking, conferences, referrals, and ongoing outreach campaigns• Managed opportunity lifecycle end-to-end from lead qualification to contract execution and account hand-off• Created visual sales presentations and delivered successfully in C-level stakeholder meetings• Partnered with finance team on pricing strategy and contract negotiations to maximize value• Developed and tracked opportunity plans leveraging Salesforce and CRM tools to enhance productivity• Worked cross-functionally to ensure seamless delivery post-sale through account management• Adapted BD messaging and positioning based on market trends and competitive landscape shifts
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Associate Director Business DevelopmentProsciento, Inc. May 2024 - Nov 2024San Diego, California, Us -
Study Start Up Management, Clinical OperationsCytokinetics Aug 2022 - Jan 2023South San Francisco, California, Us -
Senior Manager, Global Business DevelopmentProsciento, Inc. Mar 2022 - Aug 2022San Diego, California, Us
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Study Startup ManagerProsciento, Inc. Jun 2021 - Aug 2022San Diego, California, Us
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Sr. CtssProsciento, Inc. Aug 2019 - Aug 2022San Diego, California, UsSupervises the conduct of clinical trials for accuracy and efficacy. Responds to changing business needs. Creates, changes, and manages to study and staffing schedules.Ensures study procedures are performed safely and in compliance with study protocols, Standard Operating Procedures (SOPs)/Work Instructions (WIs), Good Clinical Practices (GCP), FDA, and other applicable regulations. Works with support services to ensure adequate staffing. Continuously monitors the performance of direct reports providing timely communication as it relates to performance, attendance, and conduct. Ensures that all clinical staff maintains a high level of clinical skills appropriate to their role and responsibility.Establishes a standard of excellence in clinical performance and serves as an example of clinical skills, judgment, and responsibility.Fosters teamwork, open communication, and a positive work environment.Reviews client protocols and case report forms for in house trial logistical issues.Works with the Clinical Project/Study Managers to help with the creation of protocol-specific source documents based on study case report forms.Participates in day-to-day clinical in-house study activities and procedures, ensuring efficient workflow and appropriate collection and management of research subjects’ activities.Manages and demonstrates proficiency in preparation, operation, troubleshooting, and maintenance of in-house studies phase I and II related equipment and supplies.Understands the risks and most likely problems to be encountered during in-house phase I and II procedures and how to prevent or solve these problems.Demonstrates understanding of the physiologic principles underlying specific clinical trial-related requirements in phase I and II.Manages and demonstrates proficiency in the special documentation and record-keeping requirements associated with in-house studies phase I and II.Resolves study source document discrepancies.
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Clinical Project AssociateCytori Therapeutics Inc May 2018 - Nov 2019San Diego, Ca, Us -
Clinical Trial AssociateIntercept Pharmaceuticals May 2016 - Dec 2017Morristown, New Jersey, UsInteract directly with Clinical (e.g., CRAs, managers), site staff, vendors in U.S. and Europe (other worldwide, as necessary) to provide support in project-specific tasks and the overall management of clinical trials. Support clinical project teams through documentation and report maintenance, supply inventory, and other administrative functions.maintain and manage data entry into designated clinical tracking systems to fulfill project requirements, including collecting information from clinical team members.support CRA and site requests for study supplies and coordinate shipments accordingly.maintain current study contacts information including site, CRA and vendor information.Route, track and file Clinical documents. conduct initial/ongoing review of site Clinical regulatory documentation to confirm completeness/track dates, and distribute to appropriate team members for review. assist in the maintenance of study central files for the duration of the study including assisting in the file review and reconciliation for audits, and preparing study files for archival. publish (copying, printing) study documents, packets, reference binders and arrange shipping, tracking, accordingly.regularly access study/vendor websites to run reports and ensure distribution of information to management or, if applicable, to CRAs or sites. assist in the planning, organizing and execution of project-specific meetings and writing and distributing meeting minutes.maintain project-related web pages, providing project status to CRAs, managers, sites and upper-management.assist to process invoices and expense reports from regional assist in managing site payments; determine amounts payable to clinical investigators based upon site budgets and subject visits ensuring all invoices related to the study/project are tracked and communicate with the accounting department as necessary to ensure payments. -
Clinical Research CoordinatorUniversity Of California, San Diego Jun 2015 - Apr 2016La Jolla, Ca, Us• Regulatory and QA specialist for coordinationing center ADCS. • Interpret regulations and implement quality policies, manage electroinic systems, and assist in facilitating regulatory compliance inspections.• Lead internal audits of the quality management systems to ensure compliance to SOPs and regulatory requirements.• Collaborate with IT to develop proficient Clinical Trial Management system which is part eleven compliant.• Create and maintain study start up documents including CRFs, study manuals, investigator brochures etc.• Meet scheduling and logistics (including call/web conference activation, resolution of technical issues.• Remote monitoring including conducting qualification, initiation, routine monitoring and study close-out for clinical sites.• Study file reconciliation and maintenance (electronic and/or hard copy.)• Develop solutions for routine project related issues and problems, within a limited scope.• Communicate and interact with site and study team members from site initiation until study close out. -
Tmf Management AssociateAllergan Oct 2013 - Apr 2015Dublin, Coolock, IeManagement Associate, Trial Master Files (TMF) • Provides administrative assistance in document receipt, preparation, scanning/loading, naming, filing and tracking of key information for the conduct of clinical research studies. • Responsible for high level quality control reviews of TMF documents. Assists with TMF document maintenance and • Align execution activities with agreed upon project priorities, timing, and quality specifications. The employee should have excellent organizational skills, attention to detail, flexibility, able to meet tight timelines, problem solving skills and have the ability to work independently. -
Clinical Project AssistantAllergan Sep 2012 - Oct 2014Dublin, Coolock, IeClinical Project Assistant• Validate clinical documentation for accuracy, consistency and quality standards prior to publishing to Allergan’s Trial Master Files (TMF) for quality audits by various federal regulatory bodies.• Serve as the central liaison for timely receipt of all clinical documents. Manage an agile tracking system of clinical research documents optimized for easy search via document attributes.• Responsible for high level quality control audits of TMF documents. Document TMF maintenance and tracking activities. • Manage team projects to ensure tasks are executed according to quality, priority, and timing specifications.
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Auto BrokerRose Lending Auto Exporting 2010 - 2012Office manager • Provide direct support to owner of the company and clients • Utilize Microsoft Word to compile cover sheets, invoices, and filing labels• Receive and scan vehicle inquiry reports, options list, window stickers and MSO (title)• File documents in appropriate client file, Track credit reports and qualifications• Directly contact clients and car dealerships to facilitate and coordinate sales• Locate vehicles within client budget while maximizing company revenue• Account for all fees involved in vehicle transactions when compiling invoices, including CA taxes, fees and transport for vehicles
Anthony Merlino Skills
Anthony Merlino Education Details
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California State University, Fullerton
Frequently Asked Questions about Anthony Merlino
What company does Anthony Merlino work for?
Anthony Merlino works for Konnectmd Virtual Healthcare
What is Anthony Merlino's role at the current company?
Anthony Merlino's current role is Associate Director, Business Development.
What is Anthony Merlino's email address?
Anthony Merlino's email address is am****@****ics.com
What schools did Anthony Merlino attend?
Anthony Merlino attended California State University, Fullerton.
What are some of Anthony Merlino's interests?
Anthony Merlino has interest in Economic Empowerment, Civil Rights And Social Action, Education, Environment, Disaster And Humanitarian Relief, Human Rights, Arts And Culture.
What skills is Anthony Merlino known for?
Anthony Merlino has skills like Pharmaceutical Industry, Gcp, Fda, Clinical Trials, Clinical Development, Pharmaceutical Sales, Sop, Microsoft Office, Sales Effectiveness, Cro, Biotechnology, Regulatory Affairs.
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