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Work Background
EvinovaVP of Solutions Consulting & Product Strategy
May. 2024
Medable, IncVP Change Mgmt. & Adoption
Nov. 2023 - May. 2024RemoteLead adoption and Implementation of SaaS Platform
SaaS Traning oversight
eConsent Implementation SME
Medable, IncExecutive Director, DCT Offerings
Dec. 2022 - Nov. 2023Voice of the Customer eConsent SME Collaborate with product team to achieve excellent product outcome experience and adoption
eConsent Change Management
eConsent Adoption
Regulatory Expertise
Medable, IncSenior Director, Solution Consulting
Mar. 2021 - Dec. 2022- Support building a Solution Consulting Team
- Deliver value driven presentation
- Implement discovery and tailor presentation to Biotech, Pharma, Med Device Companies
- Lead POC and sandbox environments
- Support marketing, sales and product with voice of customer type feedback
Medidata SolutionsPrincipal Consultant
Sep. 2020 - Mar. 2021
Medidata SolutionsSenior Solution Specialist
Aug. 2015 - Mar. 2021West Coast - Home Office• Lead customer needs analysis discussions
• Guide the preparation of standard or custom demonstration environments
• Participate in product demonstrations and support of customer proof of concept initiate and sandbox environments
• Lead application and/or technical product demonstrations
• Conduct web-based product seminars
• Assist with preparation of professional services estimates for inclusion in formal customer proposals
• Assist with completion of application and/or technical RFI/RFP responses
• Support effective transition of new accounts to Professional Services team
• SME on Medidata Product Platform, including Grants Managers, Design Optimizer, Rave, Safety Gateway, Coder, ePRO, eConsent, Reporting, CSA, Payments, Strategic Monitoring, Imaging, Randomization and Supply Mangament (IWRS), CTMS, Analytics, RBQM and more.
BaxaltaData Manager/ Clinical Data Analyst II / Quality Data Analyst II
Mar. 2013 - Aug. 2015westlake village, california• Collaborated with the creation, execution, and maintenance of Data Management Plans in support of clinical study deliverables, including all studies related activities such as data cleaning review, queries management, UAT, SAE reconciliation, PDs and Lab reconciliations amongst other
• Lead and collaborated activities for DBL for over 4 different Phase III studies, and 2 start-ups • Lead or contribute to the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines.
• Participated in study audits with multiple regulatory agencies like FDA and PMDA • Developed study training materials in support of CROs/Site Investigator EDC system training • Developed and employed custom reports in support of clinical data review and consistency within protocol requirements and good clinical practices
• Collaborated with Clinical Operations team to help drive SAE reconciliation line listings days by 25% • Facilitated cross-functional activities as Clinical Data Listing Reviews by representing CDM in study team meetings • Participated in development of Baxter standardized core configurations for EDC processes • CFR 21 Part 11 and GMP experience to support clinical submissions, in support of clinical study submissions
Onyx Pharmaceuticals (now Amgen)Clinical Data Manager Consultant
Oct. 2012 - Feb. 2013● Member of Clinical Data Manager Society
● Certified in Data Lock and Randomization and Selecting and Implementing EDC
● Managed agenda communication of weekly, monthly and quarterly meeting.
● Helped Senior Clinical Data Management with Phase IV and Phase III oncology studies.
● Managed Clinical Contract Vendor Budget and performance for new and current studies
● Department Event Coordinator. Logistics, marketing and communication.
CydcorData Management Specialist
Jul. 2010 - Oct. 2012California● Coordinate all data sources from the external sales team and the Client; integrate the data into the internal software systems and report numbers and results to stakeholders. ● Partner with Client to reduce their sales rejects percentage. Proven to decrease client’s rejects from 35% a week to 15% a week, in only 2 weeks.
● Create and change process to decrease manual work. Proven to decrease a 40 hours week client payment process to 15 hours week. ● Managed over 20 concurrent projects. Examples included clean up company database, reject reduction plan, outline of payment process.
● Excellent knowledge of Business Intelligence, Customer Relationship Management, Oracle and Excel.
● Create and analyze reports to determine key areas for process improvement and where the training group should focus.
Student & Au PairPersonal Assistant
Nov. 2007 - Jul. 2010California● Upon my relocation to the United States, I worked as a personal assistant and au pair to two families while I pursued my United States degree.
● Managed and created financial planning system for two families.
● Managed scheduled and communication between families.
● Assisted with a home-based business, by dealing straight with customer, handling cash flow and customer database information.
Johnson & JohnsonFinancial Analyst/Accounts Receivables
Jan. 2006 - Sep. 2007● Managed import and export documentation data entry for 3 out of the 4 Divisions of J&J. Also managed the cash flow of exports payment for 1 division. ● Implemented and managed the use of letter of credit as a payment module for countries with bad payment reputation, increasing the payment percentage from 15% to over 85%.
● Created budget and profitability analysis for new upcoming products, such as “No More Tears” shampoo and kids Band-Aid.
● Used Finance SAP module, in order to account for export and import taxes for raw material bought or sold by us.
Brazilian Government CDHUAdministrative Auxiliar
Jan. 2006 - Jan. 2007● Data entry of refinance loans information in system. Responsible for creating and presenting revenue impact analysis based on department numbers.
● Significantly helped department to hit monthly goal of 45% of total accounts refinanced, by promoting road trip to customers that were unable to come to us. Project was a success and company is still using the process today.
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