Daniel Prado
São Paulo
Summary
Over 20 years of clinical research experience, including roles as Clinical Research Associate, CRA trainer, Project Manager, and Director. Proven expertise in therapeutic areas such as Cardiology, Oncology, and Vaccines. Strong background in monitoring and management across Latin America and Canada, with a focus on regional leadership in trial monitoring organizations.
Overview
24
24
years of professional experience
Work History
Senior Director, Clinical Operations
ICON
São Paulo
01.2023 - Current
- Provided strategic direction for Clinical Operations, overseeing activities across various regions.
- Ensured teams met all delivery targets while maintaining high-quality performance.
- Managed productivity, revenue, and margin goals to optimize overall results.
- Implemented alternative monitoring models to improve operational processes.
- Operational Excellence and Quality: Accountable for oversight of overall functional quality, operational, and financial delivery in line with corporate and departmental objectives at the pan-regional, regional, or country level.
- Drive the department to achieve utilization and productivity targets at the country/region level. Ensure all clinical resources within the assigned team, region, and/or countries are meeting or exceeding performance objectives for productivity and quality, and take appropriate remedial actions and/or escalations as required.
Director
ICON, formerly PRA Health Sciences
São Paulo
01.2018 - 12.2022
- Manages clinical and administrative employees:
- Provides mentoring for Clinical Team Leads and Clinical Research Managers in Latin America and Canada.
- Provides clinical and FDA/ICH support for other areas within the company.
- Provides operational leadership and strategic business decision support to the Strategic Solution Partnership in Latin America and Canada.
- Interviews and selects team members for research projects according to sponsor needs.
- Budget management and provision for Latin America operations.
- Strategic development of Latin America, Clinical Operations. Attends the capabilities presentation, and provides input on the proposal.
- Reviews and approves expense reports for utilization and payment.
- Manages and selects non-corporate clinical staff.
- Supports clinical operations in Latin America and Canada, including local programs and clients.
- Reviews business practices for continued improvement.
Associate Director
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
Sao Paulo
02.2012 - 12.2017
- Work with the Sr. Director/Directors to establish Clinical Operations of Functional Department. Collaborate with sponsor lead and core team from both organizations to design and implement an integrated solution.
- Continue to evaluate operational efficiency that can be developed to support the assigned Functional Areas.
- Work with Sponsor to evaluate existing processes and make improvements as appropriate.
- Direct the activities of CRAs, Clinical Project Managers, Clinical Project Specialists and Clinical Trial Coordinators, Trainers, Regulatory, Clinical Logistics (as assigned).
- Ensure local Training Program needs are met in order to ensure the smooth onboarding of new hires and ongoing training of current team.
- Establish a mentoring program to ensure that the Functional Area can be scalable.
- Develop competency based skills assessments to evaluate training needs of Department and to determine career advancement opportunities for the team.
Clinical Research Manager
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
Sao Paulo
11.2008 - 01.2012
- Manage monitors in studies phases II to IV in many different therapeutic areas and project assistants;
- Interview and select team members for research projects according to Sponsor needs and/or RPS strict timelines;
- Review and approve timesheets and expense reports for utilization and payment;
- Identify training needs. Organize and / or deliver training to team members;
- Evaluate employee performance through Sponsor feedback and established performance metrics;
- Provide overall management of research operations;
- Plan clinical resources needs and timely deploy them, upon approval;
- Provide supportive management to Non-corporate clinical staff, interact with other departments for business operations;
- Assist Strategic Development in assessing workload for projects. Attend capabilities presentations and provide input to proposals as necessary;
- Develop good rapport and communicate effectively with the appropriate Project Manager or responsible for leading projects &
Lead Clinical Research Associate
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
Sao Paulo
04.2007 - 11.2008
- Driving and executing monitoring plans, ensuring site GCP compliance, writing trip reports, resolving issues and facilitating open issue resolution, working on recruitment strategies, and monitoring safety at the site.
- Role of CRA Trainer being responsible for training of new hired monitors in Latin America and operating as liaison for peculiar sponsor's procedures, forms and tools.
- Role of Superuser, in-depth training and acknowledge, on monitoring applications, for support to monitors and Site staffs on clinical study execution.
- Role of Unblinded Project Manager for Latin America sites for studies with Unblinded team responsibilities include: Blindness maintenance, stock control, monitoring plan management and trip report review.
Sr. Clinical Research Associate
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
Sao Paulo
10.2005 - 03.2007
- Operating as the main point of contact for the site during a study. Driving and executing monitoring plans, ensuring site GCP compliance, writing trip reports, resolving issues and facilitating open issue resolution, working on recruitment strategies, and monitoring safety at the site.
- By performing site qualification visits as assigned, site initiation visits and site training, routine monitoring visits, and site close-out visits. Performing investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).
Clinical Research Associate I and II
Parexel
Sao Paulo
10.2003 - 10.2005
- Identify, select, initiate, and close out appropriate investigational sites for clinical studies.
- Monitor those sites in order to ensure that studies are carried out according to the study protocol, in accordance with ICON SOPs, applicable regulations, and the principles of ICH-GCP.
- Provide a benchmark of monitoring competence to inexperienced/less-experienced colleagues.
Clinical Trial Assistant
Parexel
Sao Paulo
07.2003 - 09.2003
- Clinical Research Associate on study visit preparation, project management spreadsheet preparation, site regulatory packages preparation and protocol submissions.
Logistic Assistant and Trainee
Parexel
Sao Paulo
05.2002 - 09.2003
- To contribute to all operational aspects of the Logistics Department to ensure the optimal delivery of logistics solutions to sponsors.
- To collect, review, analyze, and model all data pertaining to the movement of Investigational Drug, kits and samples to and from sites. Including IVRS Management
Study Coordinator Trainee
Hospital e Maternidade Celso Piero
Campinas
07.2001 - 05.2002
- Assisting Study Coordinator on clinical studies with arthritis and osteoporosis. Responsibilities included: CRF fulfillment, blood samples collection and processing and study visit schedules.
Education
Graduate - Pharmaceutical Sciences
Pontifícia Universidade Católica de Campinas
Campinas, SP, Brazil12.2002
Skills
- Clinical operations management
- Regulatory compliance oversight
- Project and budget management
- Operational efficiency strategies
- Team leadership and development
Languages
- English, High, High, High, High
- Portuguese, High, High, High, High
- Spanish; Castilian, High, High, High, High
Personal Information
Title: Senior Director, Clinical Operations
System Experience
EDC, DATATRAK
Timeline
Senior Director, Clinical Operations
ICON
01.2023 - Current
Director
ICON, formerly PRA Health Sciences
01.2018 - 12.2022
Associate Director
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
02.2012 - 12.2017
Clinical Research Manager
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
11.2008 - 01.2012
Lead Clinical Research Associate
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
04.2007 - 11.2008
Sr. Clinical Research Associate
PRA Health Sciences formerly ReSearch Pharmaceutical Services (RPS)
10.2005 - 03.2007
Clinical Research Associate I and II
Parexel
10.2003 - 10.2005
Clinical Trial Assistant
Parexel
07.2003 - 09.2003
Logistic Assistant and Trainee
Parexel
05.2002 - 09.2003
Study Coordinator Trainee
Hospital e Maternidade Celso Piero
07.2001 - 05.2002
Graduate - Pharmaceutical Sciences
Pontifícia Universidade Católica de Campinas
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