Michael Scarpone Email & Phone Number

Basel, Baselstadt, Ch

• Demonstrates full knowledge and understanding of clinical research phase I-IV.• Accountable for program activities for US Oncology Medical Operations.• Possesses Expert clinical knowledge of outsourced trials.• Negotiates and finalizes master contracts, CRO Agreements, clinical trial agreements, IIT agreements and amendments, Consulting Agreements and CDAs independently.• Leads collaborations with clinical trial team, study start up groups, Investigational sites and vendors to verify and develop budget and negotiate cost savings.• Leads cross-departmental collaboration and alignment between clinical including templates and required language with Risk Management, Regulatory, QA, and Inventions and Patents departments.• Leads cross-functional resolution of issues surrounding subject injury, intellectual property, confidentiality and compensation while ensuring solutions are within the framework of the US legal and compliance requirements.• Meets anticipated internal and external timelines independently.• Works closely with Sr. Director of Medical Operations to ensure timely execution and streamlined efficient negotiations/management.• Owns and drives productivity improvements to achieve efficiency and effectiveness year over year across US Oncology Medical.• Reports savings and productivity through establishment of baselines and processes to measure and track results.• Coordinates the capturing and reporting of data related to US Oncology operational performance.• Identifies risks, develops, and implements contingency plans.• Develops strong working relationships and establishes credibility with internal and external customers.• Participates in and demonstrates an understanding of the vendor selection and management process.• Demonstrates full knowledge and understanding of Informed Consent Forms (ICF) and IRB, clinical trial privacy regulations, study start-up processes, and required trial master file documentation.

Basel, Switzerland, Ch

• Negotiates and ensures accuracy and quality in the review, and finalization of relevant documents including: contracts, informed consent, CDAs and FMV.• Collaborative program management activities for US Oncology including Sponsored Studies, TPS and HEOR.• Aids in the development of templates, tools, processes, and metrics to increase transparency, drive efficiency, and enable the successful delivery of programs.• Consults and collaborates with internal legal, privacy and other groups as necessary to obtain information and guidance to resolve issues.• Contributes to the development of processes, training materials, SOPs, and WPs for program areas.• Manages time, priorities, and resources effectively and meets established goals within expected timeframes.• Conducts data collection and analysis as required to drive efficiency, process improvements and compliance.• Interface with internal and external stakeholders including but not limited to clinical sites, vendors, clinical and HEOR teams, finance and GDD.• Supports simplification and productivity initiatives including establishment of baselines and processes to measure and track results.• Monitors projects and works to identify and mitigate program risks to minimize exposure to the department and the company.• Proactively participates in Clinical Trial Innovation, with the objective to optimize value, time, resources and risks, in Phase I to IV clinical trials for US Oncology.• Supports processes to monitor vendors, measure performance, and assists with the resolution of vendor management and issues as needed.

Basel, Switzerland, Ch

• Reviews Informed Consent Forms (ICFs) and HIPAA documents, including New Novartis template ICFs and Amendment Template ICFs, Site Specific ICFs pre and post-IRB review/approval for all US Clinical Development & Medical Affairs (CD&MA), Sponsored and Investigator Initiated, and Translational Clinical Oncology (TCO) Trials• Interfaces with internal and external stakeholders, including but not limited to: academic sites, local IRBs, site coordinators, contract managers, and clinical leads• Communicates with legal regarding terms of contract, PHI, ICF and communicates alternatives to clinical and sites• Confirms language used in IRB approved ICFs contains all Novartis required elements• Works with Central IRBs to negotiate standard template language in the ICF• Interfaces with academic research centers, IRBs, Novartis Contract Manager, Trial Leaders, and NPC Legal (including Privacy Officer) to develop alternate, pre-approved Novartis language.• Maintains electronic repositories, including tracking of ICFs, contracts, budgets, and confidentiality agreements into an Access Database• Onboard and train new associates on the ICF review process• Cross-training medical operations employees on the ICF review process• Study start-up activities for Novartis Sponsored studies, including collecting and analyzing regulatory documents, including the 1572, Financial Disclosure Forms (FDFs), protocol signature pages, Investigator Brochure (IB) receipt forms, CVs and Medical Licenses• Reviewing and negotiating legal agreements, including Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and budgets for initial and amended site contracts• Supporting HE&OR teams by reviewing and executing Task Orders and Amendments

San Francisco, Ca, Us

Providing Services to Novartis Pharmaceuticals• Review Informed Consent Forms (ICFs) and HIPAA documents, including New Novartis template ICFs and Amendment Template ICFs, Site Specific ICFs pre and post-IRB review/approval for all US Clinical Development & Medical Affairs (CD&MA), and Translational Clinical Oncology (TCO) Trials• Organizing and maintaining electronic data repositories• Aiding in the development of site-specific master ICF language• Review IRB Specific Template language (i.e. Central IRBs, including Quorum and WIRB) to ensure Novartis requirements are included in all templates

Chester, Pa, Us

• Part of a team that has been ranked in the top 5 in the company in 2015. Criteria is based on amount of appointments, demonstrations to potential clients and sales volume• Generated over six-hundred new clients for current and future sales• Interface with decision makers on a daily basis• Work in various outside business development positions including retail and event marketing• Provide thorough knowledge and promotion of Power's products and services to prospective and existing clients.• Strong knowledge of eco-friendly, green remodeling products and its benefits to the consumer• Participate in ongoing training camps on a weekly basis

Mooresville, Nc, Us

Responsible for assisting customers with all of their shopping needs including assisting customers in the selection, demonstration, preparation and loading of merchandise. Also responsible for responding to customer inquiries throughout their shopping experience including promoting customer loyalty plans and/or extended protection/replacement plans where appropriate.

West Trenton, Nj, Us

• Reviewed grant approvals for different counties within New Jersey for Hurricane Sandy relief and ensured money was dispensed accordingly.• Effectively communicated with county representatives to determine money specified on the documents was correct and submitted to njemgrants.org.• Utilized organization and planning skills when scheduling interviews for over one-hundred applicants for Hurricane Sandy funding.• Managed team in creating a training manual to assist NJ representatives on the usage of the njemgrants.org website.