All Monitoring Activities at different sites located in Florida, Giorgia, and Puerto RicoIMV - Gout Study Phase 2BClinical Monitoring tasks. Center ManagementResolution of issues and detection of findings.Permanent contact with the site's staff providing support for the proper development of their functions and resolution of issues that may be detected.Reporting of findings- SAE- Deviations- Ethics Committee and MOH entities Review and reporting of missing materials for study.Follow-up on patient recruitment and retention - Maintain updated VTMFReview Metrics and work with centers to meet client-sponsor expectations ISF reviews and updateVisit reports review- IP review

Responsible for coordinating with specialists the collection of material, reviewing and transmitting images, surgical videos as required directly to the sponsor's server ensuring the quality of the source information and preserving the anonymized information. Project Lead.

A dynamic role of SRCRA, supporting a junior-level team with a primary focus on data entry, review, and reconciliation. In this capacity, I am responsible for engaging with CRAs, CROs, Medical Doctors, and Nurses, adhering to oncology imaging guidelines. Conduct audits, including for Cause audits, and prepare audit reports. Review and assess responses to audit findingsPrepare for and support customer audits and regulatory authority inspections. Serve as lead auditor and provide training and mentorship to junior auditors. Verification of quality of Data (SDV)Review and alignment of serious and non-serious adverse event reports according to CTCAE and support in drafting the report to be submitted by the site to the IRB.Traveling to Mexico one week per month to perform IMV, data review, and issues resolution CRA activities to ensure adherence to protocol and regulatory requirements. Providing support in monitoring activities and serving as a point of contact for data-related issues. Responsible for developing study metrics and dashboard creation.Imaging Expertise: Demonstrated familiarity with imaging for cancer studies, specifically distinguishing between ultrasound, CT, and MRI scans.

Clinical Monitoring tasks. Center ManagementResolution of issues and detection of findings.Mentoring new members and training less experienced monitors providing support for the proper development of their functions and resolution of issues that may be detected.Reporting of findings- SAE- Deviations- Ethics Committee and MOH entities Review and reporting of missing materials for study.Follow-up on patient recruitment and retention Eliminate backlog- rescue visits at the other sites Attend training with sponsor-client Maintain updated VTMFReview Metrics and work with centers to meet client-sponsor expectations ISF review and updateVisit reports review

Clinical Functional Service Partnerships ( Clinical FSP)Clinical Monitoring tasks. Center Management- Co monitoring - Mentoring Resolution of issues and detection of findings.Mentoring to new members and training to less experienced monitors providing support for the proper development of their functions and resolution of issues that may be detected.Reporting of findings- SAE- Deviations- Ethics Committee and MOH entities Review and reporting of missing materials for study.Follow-up on patient recruitment and retention Eliminate backlog- rescue visit at the other sites Attend training with sponsor-client Maintain updated VTMFReview Metrics and work with centers to meet client-sponsor expectations ISF review and updateSite preparation for Sponsor Audit – Attending without Finding

• Regulatory´s expert-Peru Design of the Protocol, Drug and device Brochure and ICF- Official designer.• Medical writer • Developed team communications and information to organization meetings.• Negotiated agreements between investigators and vendors to clarify misunderstood directions and resolve conflicts affecting performance.• Regulatory Procedures

• Regulatory´s expert-Peru Design of the Protocol, Drug and device Brochure and ICF- Official designer.• Medical writer • Developed team communications and information to organization meetings.• Negotiated agreements between investigators and vendors to clarify misunderstood directions and resolve conflicts affecting performance.• Regulatory Procedures

• Responsible for guaranteeing the medical supply• Resolve conflicts of physicians with the institution.• Recruiting and interviewing new medical personnel• Review clinical studies submitted and approve their development in the clinic as a research center.• Emergency room responsible – COVID-19• Coordinate, implement, and develop the areas of greatest demand for greater productivity in accordance with current regulations.• Schedule compliance• Physicians distribution – Schedule compliance responsible

• Manager in charge to supervise all administrative procedures.• Verify and provide support and advisory in Clinical Operation procedures. Identify potential sites in Peru.• Worked with customers to understand requirements and provide exceptional service.• Devoted special emphasis to punctuality and worked to maintain an outstanding attendance record, consistently arriving to work ready to start immediately.• Managed quality assurance program including on-site evaluations, internal audits, and customer surveys.

Senior Project Manager/ Clinical Lead (January 2019 to July 2019)• Manager in charge to supervise all administrative procedures.• Verify and provide support and advisory in Clinical Operation procedures. Monitoring Audit -QC, provide support at the SC to respond to the queries and prepare de SIF • Maintained tactical control of project budgets and timelines to keep teams on-task and achieve schedule targets.• Took an active role in company growth by consistently providing quality customer service to promote growth and retention.• Perform Quality control for all studies and prepare the site to attend an Audits visit (FDA, Sponsor). Audit completed without findings• Managed quality assurance program including on-site evaluations, internal audits, and customer surveys.Manager of Business Development and Sales (January 2019 to July 2019)-FOMAT SMO• My responsibility was to identify potential sites in Florida and develop new contracts between them.• Developed compelling presentation decks to gain approval for ideas and communicate results.• Forged and nurtured impact relationships with sponsors to cultivate loyalty, boosting customer satisfaction.

Design protocols, review, develop, and Advisor in Clinical Research for Perú and Latinoamerica.The regulatory process, Q, A, and othersIMMUNOPHOTONICS- ESKE CORPORATION – Lima, PeruExternal Advisor Regional Clinical Lead January 2015 to January 2016• Sponsored by investigators from Harvard University.• Regulatory´s expert-Peru Design of the Protocol, Drug, and Device Brochure and ICF- Official designer.• Medical writer • Developed team communications and information to organization meetings.• Negotiated agreements between investigators and vendors to clarify misunderstood directions and resolve conflicts affecting performance.• Regulatory Procedures

• Regulator’s expert-Colombia.• Protocol designer.• Managed quality assurance program including on site evaluations, internal audits and customer surveys.

Medical writer and Clinical trial conduction

Project Manager- SrCRA (March 2009 to September 2011)• Lima-Perú and Caracas and Carabobo-Venezuela Senior Clinical Research Associate- Clinical Research Manager- Business and Development In charge of the clinical trials in Peru and Venezuela Sites selections, SQV, SIV, SMV, COV Regulatory procedures, protocol submission and follow up in the IRB and MOH, Grants ‘negotiation, review of the contracts, develop a database in all specialties.• Direct reports with the sponsors according to the results in the country, attend the meeting with the sponsors, Found the services necessaries for develop the task in my country.• Clinical trial in Oncology.• Manager in Business Develop for Latin America.• Found new opportunities with new potential clients to develop business in Latin America working with my partners in the region, developing economic Proposals to develop strategic material for the presentation at the new potential clients, meetings with potential clients for the presentation of the company with direct report to the Genexion´s CEO.

• Protocol Advisory Device developed for Medtronic.• Review the design of the protocol, design the CRFs, and review the final version completed.• Review the CRFs with all data and generate the queries necessary to clarify the questions.• Submission of the study at the IRB, contact, and sites selections, SQV, PSV, SMV, and close visit, Lima Peru

• External Advisor YALE UNIVERSITY professors Phase I Clinical Trial- Medical Device. • Protocol designer, design the CRFs and review the final version completed.• Review the CRFs with all data and generate queries• Regulatory activities• Site Selections, SQV, PSV, SMV, COV• Produced detailed reports outlining key issues and proposed solutions.

• Clinical Research Associate as a contractor to work for two clinical trials in DPOC(EPOC).• Assessed adherence to procedures, practices, and all applicable regulatory requirements.• Reported general issues directly to management promptly for efficient problem-solving and resolutions.• Monitoring activities

Develop the Clinical Operations in Peru and Colombia.• Maintained awareness of current developments in areas relative to assigned projects.• Worked closely with data management and site teams to resolve discrepancies.• Participated in training sessions and workshops by presenting reports from any conferences attended.• Checked drug storage procedures for compliance with protocols and SOP requirements.• Monitored progress throughout the duration of the trial and documented activities for critical CRFs and SAE records.• Observed studies to safeguard the continued effectiveness of the investigator, clinical site team, and facility.• Negotiated and finalized site payments.• Liaised with vendors for protocol adherence and checked clinical supplies at investigational sites.• Teamwork

In the studies where I participated, I collaborated in the regulatory procedures submission and all monitoring tasks.• Responsibilities have spanned from the initiation to the study and closeout.• Assessed adherence to procedures, practices, and all applicable regulatory requirements.• Reviewed clinical data, source documentation, case report forms, and investigative site regulatory files.• Coordinated with project lead for effective resolutions of study-related issues.• Participated in training sessions and workshops by presenting reports from any conferences attended.• Created and maintained a database and records filing system to document data on specimen collection, processing, and storage.• Monitored progress throughout the duration of the trial and documented activities for records.

• Followed informed consent processes and maintained records.• Worked with principal investigator and sponsors to facilitate daily trial activities and ensure• compliance with research protocols.• Monitored unit budget to ensure financial objectives were met.• Collected data and followed research protocols, operations manuals, and case report form requirements.• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.• Screened patient records, databases, and physician referrals to identify prospective candidates for research• studies.• Maintained compliance with protocols covering patient care and clinical trial operations.

Monitored market trends and competitor performance and analyzed gaps to update promotional strategies and maximize sales.• Directed planning, budgeting, vendor selection, and quality assurance efforts.• Conceptualized and deployed enhanced product features and optimized implementation for use in marketing strategies.• Liaised with clients to develop a deep understanding of business needs and the current market landscape.• Collaborated with sales, marketing, and support teams to launch products on time and within budget.• Defined and analyzed metrics to measure product performance.• Medical advisory to develop product strategies.• Training of staff in the area• Organization of meetings with KOL Oncologists in the region - Peru - Colombia - Argentina - Venezuela.• Presentation of clinical studies and progress to KOLs and other medical professionals.