Leslee Bartolotti

Experience

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  Big Picture Photography

  Jan 2008 - Dec 2012

  Owner/Photographer

  • Manage all aspects of business including customer service, bookkeeping and setting appointments• Process all jobs in post-production

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  CI-GROUP

  Mar 2010 - Aug 2010

  Promotions Coordinator

  Project management of promotional items from concept to delivery for Fortune 500 clients. Managed project budget, sourced vendors, managed timeline and delivery. • Coordinated promotional marketing, managed materials, project budget for multiple high-end clients from asset creation to delivery • Communicated with clients to assess the target market and promotional goals

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  Bristol Myers Squibb

  Oct 2011 - Jan 2019

  • Managed 18 direct reports (including FSP employees) resourcing book of work for 390 clinical trials encompassing all phases of development and therapeutic areas globally• Managed and hired team responsible for data management in CTMS of clinical trials including all phases of development and therapeutic areas globally, including FSP staff• Executed yearly performance reviews for direct reports, training compliance, development, and career opportunities• Created detailed Job Shadowing program to facilitate development of employee talent. Program resulted in three direct reports moving into new roles• Participated in work stream for TMF (Veeva Vault) integration as a contributor for essential capabilities related to CTMS requirements for clinical trial data• Participated as SME for TMF (Veeva Vault) working with CRO partners Show less Managed and supervised a team responsible for the receipt, review and tracking of invoices from vendors and/or investigative sites. Ensured team members completed timely approval of payments from operations with the appropriate Grant of Approval.• Provided guidance and training on how to process invoices using the appropriate systems and/or coordination with outsourced service function for appropriate payment.• Confirmed all invoices were compliant with terms of contracts safeguarding against future discrepancies with clients saving the company 10% on each contract. Show less Assisted in large scale Request for Proposal evaluating multiple software platforms and system requirements. Developed global training program of Digital Asset Management system (DAM) for internal and external stakeholders. Developed process documentation for role as well as developed Customer Service plan for collecting required information for all assets entered into the Digital Assets Management System for Global Librarians. Organized and prepared digital files for Digital Asset Database. • Managed system taxonomy including versioning requirements. • Managed marketing materials in DAM using metadata in faceted search system. • Average monthly uploads approximately 1,000 - 2,000 assets. • Average monthly downloads approximately 4,000 assets. • Tracked and managed system users for Enterprise Content Management system as well as SharePoint sites. • Completed UAT testing for new Digital Asset Management system. Show less

  • Clinical Trials Support Specialist Manager

    Mar 2016 - Jan 2019

  • Grant Administration Assistant Manger

    Jul 2015 - Mar 2016

  • DIGITAL ASSET MANAGEMENT SYSTEMS Team Leader

    Oct 2011 - Jul 2015
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  Syneos Health

  Jun 2019 - Feb 2020

  Trial Master File Lead

  On assignment with Glaxo Smith-Kline to develop and maintain Trail Master File and TMF Oversight Plans.

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  ExecuPharm

  Feb 2020 - Apr 2021

  TMF Study Owner

  On assignment with Pfizer to develop and maintain Trail Master File.

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  Treximo (A ProPharma Group Company)

  Apr 2021 - May 2022

  Clinical Document Management Lead on assignment with Cara Therapeutics

  On assignment with CARA Therapeutics to develop and maintain Trial Master File.

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  Cara Therapeutics

  May 2022 - Jan 2024

  Clinical Document Management Lead

  Clinical Document Management Lead • Veeva implementation of eTMF platform (2021)• Participate in developing SOP's, process improvement, and other training materials to ensure team members' understanding and adherence to established protocols.• Author and finalize TMF work instructions and process documents.• Lead standardization and training across all programs globally.• Collaborate with Information Technology for system enhancements and configuration.• Participate in TMF Governance meeting with company leaders.• Subject matter expert for TMF across all internal study teams, Alliance Partners, and Contract Research Organizations (CROs).• Author & finalize Study Specific TMF Management Plan and Study specific TMF index.• Create Key Performance Indicators (KPIs) to be used across all internal study teams, Alliance Partners, and CROs.• TMF set-up including monitoring completeness, quality, timeliness, and content metrics from start up through closeout and archiving.• Manage internal and external user access.• Participate in eTMF internal audits, and regulatory inspections.• Periodically perform risk based TMF reviews, work with stakeholders and document owners to mitigate all findings according to TMF Management Plan.• Manage TMF external transfers and TMF archiving.• Coordinate long-term storage archival of original documents and maintain document integrity per retention policies.• Ensures optimal use of eTMF functionality by analyzing project and industry best practices and transferring manual processes into automated workflows, as possible.• Streamlined workflow processes for increased efficiency in document management tasks. Show less

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  Connect Life Sciences

  Feb 2024 - now

  TMF Consultant on assignment with Repare Therapeutics