Leslee Bartolotti
Tampa,FL
Overview
11
11
years of professional experience
1
1
Certification
Work History
Clinical Document Management Lead
Cara Therapeutics
04.2021 - 04.2022
- 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.
TMF Study Owner
ExecuPharm
02.2020 - 04.2021
- On assignment with Pfizer to develop and maintain TMF.
Trial Master File Lead
Syneos Health (Previously INC Research/inVentiv Health)
06.2019 - 02.2020
- On assignment with Glaxo Smith-Kline to develop and maintain TMF.
Clinical Trials Support Specialist Manager
Bristol-Myers Squibb
03.2016 - 01.2019
- 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 contributor for essential capabilities related to CTMS requirements for clinical trial data
- Participated as SME for TMF (Veeva Vault) working with CRO partners.
Grant Administrator Assistant Manager
Bristol-Myers Squibb
06.2015 - 03.2016
Digital Asset Management Systems Team Leader
Bristol-Myers Squibb
10.2011 - 06.2015
Education
Skills
- People & Performance Management
- Project Management
- Continuous Innovation
- CTMS
- Veeva Vault
- ETMF
- SAP
- IVRS
- DAM
- Standard Operating Procedures
- Regulatory Audits and Inspections Clinical documentation management
- Therapeutic Areas: Oncology, Cardiovascular, Chronic Pruritus
- DIA Reference Model/CDISC
Certification
TMF University, 11/01/21
Timeline
Clinical Document Management Lead
Cara Therapeutics
04.2021 - 04.2022
TMF Study Owner
ExecuPharm
02.2020 - 04.2021
Trial Master File Lead
Syneos Health (Previously INC Research/inVentiv Health)
06.2019 - 02.2020
Clinical Trials Support Specialist Manager
Bristol-Myers Squibb
03.2016 - 01.2019
Grant Administrator Assistant Manager
Bristol-Myers Squibb
06.2015 - 03.2016
Digital Asset Management Systems Team Leader
Bristol-Myers Squibb
10.2011 - 06.2015
TMF University, 11/01/21