Alejandro Pacheco Silva
Ciudad de Mexico
Summary
Site Management Associate with nearly four years of experience in clinical trial operations, adept at driving project goals within the healthcare sector. Proficient in clinical research methodologies, communication strategies, and effective time management, enhancing team collaboration and project efficiency. Demonstrated a strong foundation in Good Clinical Practice and Clinical Trial Management Systems. Eager to leverage expertise in a Clinical Research Monitoring roles, contributing to the advancement of innovative therapies through meticulous monitoring and support of clinical trials.
Overview
4
4
years of professional experience
Work History
Site Management Associate
Icon PLC
03.2023 - 02.2024
- Served as a Site Management Associate acting as support on site activation activities and global study compliance
- Responsibilities encompass collaboration with cross-functional teams to oversee site performance and adherence to study protocols
- Utilize CTMS to ensure investigator recruitment activities are accurately tracked
- Performe essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance ICH/GCP guidelines
- Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status
- Follows up with sites for trial invoices to allow the timely processing of Investigator Payments
- Performe periodic QCs and site level maintenance of the eTMF
Senior Clinical Trial Assistant
Icon PLC
10.2021 - 03.2023
- Previously held the position of Senior Clinical Trial Assistant where a pivotal role was played in supporting GTL / CTM with the required information and metrics from study, country and site level involving managing documentation, assisting with the coordination of trial activities, tracking and reporting EDC, queries, deviation, training and access compliance for the studies
Global Clinical Trial Assistant
Icon PLC
06.2020 - 10.2021
- As a CTA clinical trial coordination support was provided to Project Teams for assigned clinical trials which included tracking a wide range of key operational activities and maintenance of essential study documentation, including the TMF, CTMS, EDC, study and site training compliance.
- General support to the GTL / CTM and the cross functional team
Education
Pharmaceutical and Biological Chemestry -
Universidad Nacional Autonoma de Mexico
12.2019
Skills
- Advanced English
- Microsoft Excel advanced skills
- Time Management
- Project coordination
- Good clinical practice
- Trial oversight
- Teamwork and collaboration
- TMF, CTMS proficency
Timeline
Site Management Associate
Icon PLC
03.2023 - 02.2024
Senior Clinical Trial Assistant
Icon PLC
10.2021 - 03.2023
Global Clinical Trial Assistant
Icon PLC
06.2020 - 10.2021
Pharmaceutical and Biological Chemestry -
Universidad Nacional Autonoma de Mexico
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