Leslee Bartolotti Email & Phone Number

Tampa, FL, US

• 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.

United States

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

Remote

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

Homebased

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

Tampa/St. Petersburg, Florida Area

• 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

Tampa/St. Petersburg, Florida

• 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.
• 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.

Tampa, FL

• 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.
• 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.

Plainsboro, NJ

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

• 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

Buisness Coursework, Business

Photography

Activities and Societies: Interned in college publications department, special events photography.

Education record