REBECA PATÓN LÓPEZ
Summary
Clinical Research professional with 15+ years of experience in clinical trials, specializing in study start-up, Ethics and Regulatory submissions, and global team leadership. Proven track record managing multinational teams, delivering projects on time, and ensuring compliance with regulatory requirements. Strong expertise in site activation, vendor management, and risk management within fast-paced environments.
Clinical research is more than just a job to me; it's an extraordinary chance to transform lives through the development of new medications. I am known as a passionate and dedicated leader, committed to delivering results swiftly and with the utmost quality.
Overview
18
18
years of professional experience
Work History
Start-up Team Lead (SUL)
Precision for Medicine
08.2025
- Lead of start-up teams across multiple countries in the execution and achievement of site activation objectives within a region, ensuring project scope in terms of time, cost, and quality.
- Expert in global start-up activities and accountable for the execution of site initiation strategy and planning.
- Manages and coordinates the collection and approval of essential documents.
- Oversee customization and approval of the Informed Consent Form (ICF)
- Oversee and coordiante submissions to Institutional Review Boards/Ethics Committees (IRB/EC) and Competent Authorities/Ministries of Health (CA/MOH), as well as the delivery of Investigational Medicinal Product (IMP) release packages.
- Coordinate cross-functional stakeholders and vendors
- Provided training and potentially responsible for the development of country-specific orientation tools and documents to enhance knowledge sharing on country-specific site activation activities.
Start-up Team Manager (STM)
Pharmaceutical Product Development ( part of Thermo Fisher Scientific)
09.2020 - 03.2025
- Lead and coordinate multi-national country teams teams, driving site activation and amendment goals on a regional and global level.
- Managed project dimensions including time, cost, and quality, ensuring alignment with scope.
- Delivered precise projections, reports, and risk assessments to meet project deliverables.
- Held accountability for risk identification, escalation, and mitigation, enhancing team efficiency and site activation targets.
- Facilitated vendor setup and supervision, ensuring adherence to processes, procedures, and regulations.
- Accountable for identifying, escalating, and mitigating risks, driving efficiencies, and enhancing the team's capacity to meet site activation projections.
- Directed the project's critical path to ensure sites were 'ready to enroll' efficiently and effectively.
Senior Country Approval Specialist
Pharmaceutical Product Development
04.2017 - 09.2020
- Led the preparation, review, and coordination of local regulatory submissions (MoH, EC, and additional national applications as applicable) in alignment with global submission strategy.
- Local country expert local submission strategies, providing technical expertise and oversight in project coordination with relevant internal departments.
- Served as the primary point of contact for local investigators and regulatory authorities, ensuring timely management of submissions.
- Acted as the country-level key contact for all submission-related activities.
- Ensured submission processes for sites and studies were in sync with the critical path for site activation.
- Prepared Regulatory Compliance Review packages and liaised with the Local Start-Up team to ensure local submission activities were planned and executed in accordance with the global project submission strategy.
- Developed country and site-specific documents for Patient Information Sheets/Informed Consent Forms (ICF).
Country Approval Specialist
Pharmaceutical Product Development
07.2015 - 03.2017
- Prepared, reviewed, and coordinated local regulatory submissions (MOH, EC, and additional special national applications) in line with global submission strategy.
- Coordinated with internal functional departments to synchronize site initiation activities with agreed-upon submission timelines.
- Ensured submission processes for sites and studies were aligned with the critical path for site activation.
- Maintained communication with investigators for submission-related activities and served as the key country-level contact for Ethical or Regulatory submission matters.
- Compiled Regulatory Compliance Review packages, collaborating with the Start-Up CRA as needed.
- Developed country-specific and site-specific documents for Patient Information Sheets/Informed Consent Forms.
Senior Clinical Research Associate (Sr. CRA)
Pharmaceutical Product Development
04.2012 - 07.2015
- Conducted comprehensive feasibility activities, study initiation, site identification and selection, site initiation, and intermediate monitoring visits, including booster sessions.
- Managed site files, query resolution, and adverse event reporting, ensuring compliance and data integrity.
- Participated in interim database lock activities, investigator/site payment processing, close-out visits, drug reconciliation, file review, and archiving.
- Proficient in handling eCRFs (electronic Case Report Forms) for efficient data collection and management.
- Supported the Country Manager in start-up activities, mentoring, training, and directing the local study initiation team.
- Identified and proposed process improvements to enhance clinical trial operations.
- Provided feedback on tools, processes, and procedures to optimize performance.
- Served as a go-to resource for operational inquiries and role-specific questions, offering expert guidance.
Clinical Research Associate (CRA)
Pharmaceutical Product Development
11.2010 - 03.2012
- Spearheaded site initiation activities, including site preparation and management.
- Conducted initiation and interim monitoring visits, focusing on reinforcement visits.
- Ensured meticulous maintenance of trial files and effective query resolution.
- Delivered timely and detailed reporting of Adverse Events.
- Actively participated in the interim database lock process.
- Processed investigator and clinical site payments with diligence.
- Led close-out visits, medication reconciliation, and file review.
- Implemented archiving processes to maintain document integrity.
- Proficiently managed eCRFs (electronic Case Report Forms).
Clinical Research Associate (CRA)
Quintiles S.L
09.2007 - 10.2010
- Executed comprehensive site initiation, routine monitoring, and close-out visits.
- Diligently reported Adverse Events and Serious Adverse Events.
- Efficiently resolved data queries and supported interim and final database lock activities.
- Managed investigator/site payments and maintained meticulous trial documentation.
- Handled both electronic and paper Case Report Forms (CRFs) with proficiency.
Clinical Research Associate-Trainee (CRA Trainee)
Quintiles S.L
12.2006 - 09.2007
- Assisted the Clinical Project Manager in presenting to Institutional Review Boards (IRBs).
- Prepared and compiled regulatory submission packages for approval.
- Systematically maintained and updated clinical trial files.
- Conducted feasibility studies for research site selection.
- Coordinated the distribution of laboratory kits, Case Report Forms (CRFs), and other supplies to research centers.
- Actively participated in regular team meetings and teleconferences.
- Accurately and promptly updated Clinical Trial Management Systems (CTMS).
Education
MSc. - Clinical and Pharmaceutical Research
EPHOS (Universidad de Alcalá)
Madrid01-2008
BSc. - Biology
Universidad de Alcalá
Madrid01-2006
Skills
- Clinical Trials Management
- Study Start-up & Site Activation
- Ethics and Regulatory Submissions
- Global Team Leadership
- Stakeholder and Vendor Management
- Risk Management
- GCP Compliance
- Clinical Monitoring
- Risk management and analysis
- Budgeting and financial forecasting and management
- Conflict resolution
- Persuasion and influencing
- Time management and prioritization
- Analytical thinking and decision-making
- Adaptability and flexibility
- Learning from success and failure
Languages
Spanish
English
Timeline
Start-up Team Lead (SUL)
Precision for Medicine
08.2025
Start-up Team Manager (STM)
Pharmaceutical Product Development ( part of Thermo Fisher Scientific)
09.2020 - 03.2025
Senior Country Approval Specialist
Pharmaceutical Product Development
04.2017 - 09.2020
Country Approval Specialist
Pharmaceutical Product Development
07.2015 - 03.2017
Senior Clinical Research Associate (Sr. CRA)
Pharmaceutical Product Development
04.2012 - 07.2015
Clinical Research Associate (CRA)
Pharmaceutical Product Development
11.2010 - 03.2012
Clinical Research Associate (CRA)
Quintiles S.L
09.2007 - 10.2010
Clinical Research Associate-Trainee (CRA Trainee)
Quintiles S.L
12.2006 - 09.2007
BSc. - Biology
Universidad de Alcalá
MSc. - Clinical and Pharmaceutical Research
EPHOS (Universidad de Alcalá)