Eduardo Escotto Puga
TMF Lead
Mexico City
Summary
Dynamic TMF Lead at ICON PLC with a proven track record in enhancing TMF quality and completeness for clinical trials. Known for fostering collaboration and communication, I excel in problem-solving and attention to detail, ensuring audit readiness and successful project outcomes. Committed to continuous improvement and effective stakeholder engagement.
Overview
7
7
years of professional experience
1
1
Certification
Work History
TMF Lead
ICON PLC
05.2024 - Current
- Primary point of contact for the TMF of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.
- Lead the setup of the Study in TMF system.
- Drive completeness and quality of TMF content for all assigned clinical trials until study close out.
- Oversee documentation flow within projected timelines and determine course of actions to prevent and remediate delays and errors.
- Manage TMF activities in accordance with the contracted budget for TMF Operations.
- Lead the development and implementation of the TMF specifications, such as process and system changes.
- Develop and foster sponsor relationships through effective TMF management and communication.
- Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.
- Effectively monitor and report on progress of the TMF to all stakeholders.
- Facilitate communication and interaction among study team members from the set up until the closing of the TMF for a clinical trial.
- Apply lessons learned to continuous improvement of documentation management practices across study teams.
- Provide education, feedback and guide Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
Principal Project Support Coordinator
PPD - Thermo Fisher
07.2019 - 05.2024
- Direct support to the study team, mainly to the Project Leads and Clinical Trial Managers; study team training tracking, audit readiness preparations throughout the different phases of the study (start-up to close-out) according to the company´s policies and SOPs
- Cross-functional liaison overseeing administrative tasks
- Lead of PSC teams assigning tasks, overseeing the quality and resources. Guiding and supporting the team through TMF and study-related activities
- Responsibility of the setup, quality and maintenance of the clinical/administrative documents in the eTMF. Perform quality checks of completeness
- Periodical reviews at different filing levels ( Central, Country and Site levels)
- Completion of eTMF metrics reports and other reports
- Creation of reports supporting the PLs and CTMs
- Clinical systems set-up and maintenance; CTMS, Veeva Vault among others
- Access management for PPD´s and contracted/vendor systems
- Trainer for national and international colleagues
- Lead for a dedicated client support group ; special eTMF and file review doubt resolution and training providing expertise to fellow colleagues
- Evaluator assessing file review performance on other clinical trial coordinators
- Study team meeting support; scheduling and creation of agendas and minutes
Health and Quality Manager
Lonza - Capsugel
02.2018 - 07.2019
- Responsible for the Quality Management System and the documentary system.
- Update and application of the quality system to ISO 9001: 2015
- Supervision of the storage/distribution of hard gelatin empty capsules
- Responsible for receiving and attending the audits of the different Capsugel clients
- Supervision and training of personnel for GSDPs, safety and hygiene within the warehouse
Education
Bachelor Of Science - Pharmaceutical And Biological Chemistry
Universidad La Salle
Mexico City11.2017
Skills
- Teamwork and collaboration
- Problem-solving
- Critical thinking
- Attention to detail
- Flexible and adaptable
- Dependable and responsible
- Excellent communication
- Active listening
- Friendly, positive attitude
Accomplishments
- Graduated from the University with outstanding performance (9.1/10)
- SME in eTMF platforms like Veeva Vault
Certification
- IELTS C1 certification
- WES Verified International Academic Qualification
- John Hopkins University - Design and interpretation of clinical trials (10 hrs)
- Project Management Essentials (Skillsoft courses)
Languages
English
Advanced (C1)
Spanish
Bilingual or Proficient (C2)
German
Elementary (A2)
Timeline
TMF Lead
ICON PLC
05.2024 - Current
Principal Project Support Coordinator
PPD - Thermo Fisher
07.2019 - 05.2024
Health and Quality Manager
Lonza - Capsugel
02.2018 - 07.2019
Bachelor Of Science - Pharmaceutical And Biological Chemistry
Universidad La Salle
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