Summary
Overview
Work History
Education
Skills
Affiliations
Language Capabilities
Us Visa
Personal Information
Publications
Therapeutic Experience
Other
Language Capabilities
Certification
Timeline
Generic
Alfredo San Martin

Alfredo San Martin

Lima

Summary

I am a Experienced Medical Doctor specializing in Clinical Research since 2003. My passion is Clinical Research because is the foundation of modern healthcare and drives innovation and medical advances that can change people's lives. And I am part of it. The mission of my life is to help people to live longer and better. Dedicated to advancing scientific understanding of diseases, fostering medical innovation, and enhancing global health outcomes. I am a strongly believer that the team work is the better way to gather the knowledge and skills of good professionals to get the better results of a project. I enjoy so much the team work and to support and teach the younger professionals to continue with the way I walked and to increase the research community with people with my same way to think. Seasoned Associate bringing hands-on experience in business operations and client management. Demonstrates adeptness at fostering strategic partnerships, streamlining processes, and enhancing operational efficiency. Strong communication skills with a knack for problem-solving and team collaboration. Previous work has resulted in improved customer satisfaction and significant process optimizations.

Overview

30
30
years of professional experience
1
1
Certification

Work History

Principal Regulatory Affairs & Study Start Up Associate

Resolution Latin America Peru
07.2024 - Current
  • Report to Regulatory Affairs Manager (RAM) and country management when applicable. Support Company Management in achieving the Company’s objectives.
  • Obtain approvals from Ministry of Health (MoH) other regulatory bodies, when applicable, for clinical studies and achieving the deadlines agreed between ReSolution and Sponsor for study initiation.
  • Ensuring that all regulatory processes are implemented in compliance with local and international regulations, as well as with the relevant SOPs (ReSolution or Sponsor).
  • Supervise, approve and verify the Regulatory Packages to be sent to IRBs and collaborate in the appropriate training of the study teams, as requested by the Project Lead (PL – is the person who leads a study such as a Project Manager (PM), Lead CRA, etc.) and ReSolution Senior Management.
  • Supervising the quality of all regulatory documentation (related to approvals and notifications to/from Site´s Institutional Review Boards [IRBs]).
  • Engaging in a proactive follow-up of the regulatory packages that have been submitted to the MoH and the IEC.
  • Involvement, management and/or support to any study set-up related activities as instructed by RAM.
  • Participate/collaborate in the conduct of feasibilities studies.
  • Involvement, management and/or support of any Regulatory Consultancy contracts.
  • Support ReSolution´s Business Development efforts as required.
  • Maintain and understand appropriate metrics and act based on these results.
  • Provide support during audits, inspections and assessments, if required.
  • Attend all the required training sessions (Sponsor and/or ReSolution).
  • Attend work-related meetings, dinners or other appropriate social activities when required.

Principal CRA / Regulatory Specialist

Resolution Latin America Peru
07.2021 - 06.2024
  • Support Company Management in achieving the Company’s objectives.
  • Act as the link between the sites, the ReSolution Project Team (PT) and the Sponsor Team.
  • Actively interact with the PM, the Regulatory and Medical Functions, as well as with Senior Management.
  • Champion the objectives and goals of both the Sponsor and ReSolution in the region and to work towards the success of each Project under his/her remit by ensuring the quality of all study activities.
  • Work in conjunction with ReSolution´s Senior Management in the ReSolution Latin America (ReSolution) global development planning.
  • Define Business Operations strategy and objectives in alignment with ReSolution strategy and objectives.
  • Manage and support resource planning both global and project-specific.
  • Ensure appropriate interaction between Clinical Operations, Business Development and all the support Departments.
  • Advises, consults, and makes final recommendations to all aspects of clinical regulatory.
  • Request training for the team under his/her supervision.
  • Participate/collaborate in the conduct of feasibilities studies in coordination with the PM, Managing Director Clinical Operations, Business Development and/or Medical Advisor.
  • Keeps abreast of regulations, trends, developments, and advances in the global regulatory environment.
  • Supports impact assessments of regulatory documents, submissions and guidelines.
  • Understand metrics and act based on these results.
  • Train and support peers as required.
  • Provide support during audits, inspections and assessments, if required.
  • Attend all the required training sessions (Sponsor and/or ReSolution).
  • Attend work-related meetings, dinners or other appropriate social activities when required.
  • Organize meetings, trainings, conferences, etc. when required.
  • Availability for international or local travel as required.
  • Be responsible for keeping training requirements up to date.
  • Commitment to ReSolution Latin America´s (ReSolution) standards and values of Quality, Excellence, Integrity and Accountability.
  • Highest ethical standards.

Clinical Research Associate III (SWAT Team)

PRA Health Sciences
05.2021 - 07.2021
  • Applies knowledge of PRA’s policies and procedures.
  • Demonstrates excellent written and oral communication.
  • Demonstrates excellent knowledge of ICH/GCP.
  • Displays ability to manage investigative sites to facilitate trial deliverables.
  • Demonstrates ability to escalate issues appropriately.
  • Conducts monitoring to confirm subject safety and data integrity.
  • Describes and demonstrates the principals of IP accountability.
  • Identifies scientific misconduct at the site level.
  • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms.
  • Mentors CRAs new to the position or company.
  • Serves as an observation visit leader.
  • Conducts monitoring evaluation visits.
  • Assists team lead in the development of trial tools or documents.
  • Assists with CTM tasks.
  • Participates in the development of process changes/improvements.
  • Presents at client meetings/Investigator meetings.
  • Provides training to trial teams.

Country Manager – HHCC (Home Health Country Coordinator)

MDE Services Group Limited
10.2020 - 04.2021
  • To assist in the responsibility for maintaining consistently the brand standards and in ongoing development of the Patient Services solutions.
  • Support the Home Health study teams providing regular metrics on visits, quality issues, nurse availability, organization of equipment and attend team/ client meetings as and when required.
  • The HHCC, patientprimary will frequently interact with Healthcare worker suppliers, Healthcare workers, sites, patients and clients where appropriate.
  • The HHCC role is pivotal in delivering the professionalism that is synonymous with patientprimary and crucial success factor will be to champion the culture and values of patientprimary at all times during interaction with the Client, Patients, colleagues, suppliers and the Home Health teams.

Project Manager – Sr. CRA

Peruvian Clinical Research
08.2019 - 09.2020
  • Company Overview: Lima, Peru
  • To manage key client projects.
  • Coordination and completion of projects on time within budget and within scope.
  • Oversee all aspects of projects.
  • Set deadlines, assign responsibilities and monitor and summarize progress of projects.
  • Prepare reports for upper management regarding status of projects.
  • To work directly with clients to ensure deliverables fall within the applicable scope and budget.
  • To coordinate with other departments to ensure all aspects of each project are compatible and will hire new talent as needed to fulfill client needs.
  • To coordinate internal resources and third parties/vendors for the flawless execution of projects.
  • To assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.
  • To ensure resource availability and allocation.
  • Develop a detailed project plan to monitor and track progress.
  • Manage changes to the project scope, project schedule and project costs using appropriate verification techniques.
  • Manage the relationship with the client and all stakeholders.
  • Meet with clients to take detailed ordering briefs and clarify specific requirements of each Project.
  • Delegate project tasks based on junior staff members' individual strengths, skill sets and experience levels.
  • Track project performance, specifically to analyze the successful completion of short and long-term goals.
  • Meet budgetary objectives and make adjustments to project constraints based on financial analysis.
  • Develop comprehensive project plans to be shared with clients as well as other staff members.
  • Use and continually develop leadership skills.
  • Attend conferences and training as required to maintain proficiency.
  • Develop spreadsheets, diagrams and process maps to document needs.
  • Perform other related duties as assigned.
  • Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in the office and at a site.
  • Actively participate in local Study Delivery Team meetings.
  • Contribute to the selection of potential investigators.
  • Train, support and advice investigators and site staff in study related matters.
  • Maintain good relationships with all the investigators and to give support of the scientific aspects to them.
  • Contribute to national investigators meetings.
  • Initiate, monitor and close study sites in compliance with Procedural Documents.
  • Share information on patient recruitment and study site progress within local Study Delivery Team.
  • Drive performance at the sites.
  • Proactively identify study-related issues and escalates as appropriate.
  • Update any system with data from centers as per required timelines.
  • Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
  • Cover all monitoring activities from feasibility through study close out.
  • Prepare for activities associated with audits and regulatory inspections.
  • Ensure timely submission of proper application/documents to EC/IRB and Regulatory authorities.
  • Ensure timely customization and completion of the Contract Study Agreements for designated studies.
  • Track and manage agreed payments at study site level.
  • Contribute to process improvements, knowledge transfer and best practice sharing.
  • Lima, Peru

CEO / Project Manager / Clinical Research Advisor

SM Global Group
09.2016 - 07.2019
  • Company Overview: Lima, Peru
  • Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in the office and at a site.
  • Actively participate in local Study Delivery Team meetings.
  • Contribute to the selection of potential investigators.
  • Train, support and advice investigators and site staff in study related matters.
  • Maintain good relationships with all the investigators and to give support of the scientific aspects to them.
  • Contribute to national investigators meetings.
  • Initiate, monitor and close study sites in compliance with Procedural Documents.
  • Share information on patient recruitment and study site progress within local Study Delivery Team.
  • Drive performance at the sites.
  • Proactively identify study-related issues and escalates as appropriate.
  • Update any system with data from centers as per required timelines.
  • Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
  • Cover all monitoring activities from feasibility through study close out.
  • Prepare for activities associated with audits and regulatory inspections.
  • Ensure timely submission of proper application/documents to EC/IRB and Regulatory authorities.
  • Ensure timely customization and completion of the Contract Study Agreements for designated studies.
  • Track and manage agreed payments at study site level.
  • Contribute to process improvements, knowledge transfer and best practice sharing.
  • Prepare study packages and submit clinical studies authorization applications, and follow-up correspondence.
  • Advisory to investigator sites in local regulations, site inspection preparation, audit preparation, site standard operation procedures preparation, budget negotiation, contract negotiation.
  • Advisory to foreign sponsors in local regulations, study approvals, timelines, local depot, budget negotiation, contract negotiation, local legal representation, study design and freelance monitoring.
  • Lima, Peru

Grants Manager Central Group Member

AstraZeneca, Peru
09.2014 - 08.2016
  • To create the study budgets calculating the per-patient cost of the allocated studies worldwide.
  • To deliver budgets within expected timelines.
  • Good communication with MCs (Head Countries) and global study teams.
  • To support global study team members, head countries and delegates in Study site budget development and review process.

Senior Clinical Research Associate

AstraZeneca, Peru
09.2014 - 08.2016
  • Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at a site.
  • Actively participate in local Study Delivery Team meetings.
  • Contribute to the selection of potential investigators.
  • Train, support and advice investigators and site staff in study related matters.
  • Maintain good relationships with all the investigators and to give support of the scientific aspects to them.
  • Contribute to national investigators meetings.
  • Initiate, monitor and close study sites in compliance with AZ Procedural Documents.
  • Share information on patient recruitment and study site progress within local Study Delivery Team.
  • Drive performance at the sites.
  • Proactively identify study-related issues and escalates as appropriate.
  • Update IMPACT and other systems with data from centres as per required timelines.
  • Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
  • Cover all monitoring activities from feasibility through study close out.
  • Prepare for activities associated with audits and regulatory inspections.
  • Ensure timely submission of proper application/documents to EC/IRB and Regulatory authorities.
  • Ensure timely customization and completion of the Contract Study Agreements for designated studies.
  • Track and manage agreed payments at study site level.
  • Contribute to process improvements, knowledge transfer and best practice sharing.

Senior Clinical Research Associate

Covance Lima, Peru
06.2007 - 04.2014
  • Core Business Monitoring and Country Lead activities (Jun. 2007 – Aug. 2010).
  • Co-Source Monitoring in Merck Sharp & Dome (Aug. 2010 – May 2011).
  • Core Business Monitoring (Jun. 2011 – Apr. 2014).
  • Legal representative for Minister of Health, National Institute of Health, DIGEMID, Customs National Superintendence, Hospitals, Clinics and any other entity private or public.
  • Representative for Peruvian Association of CROs (APOICC).
  • Support Latin American extensions in Peru by assisting the new business in the country gathering, creating and/or checking documents to attract clients and improve clinical trials development in the country.
  • Support Covance Peru office in all administrative aspects.
  • Support other employees with Covance internal procedures according positions and job description.
  • Support team of Six Sigma Projects with the accurate and complete information of Clinical Trial Materials importation for Peru to reduce variability, times and costs and by this way to reduce write offs of the company.
  • Conduct Accompanied Field Visits and Qualification Visits.
  • Undertake feasibility work when requested by Manager.
  • Provide with the local regulatory knowledge and updated information in Peru to ensure an adequate and professional performance of Covance in Peru.
  • Prepare study packages and submit clinical studies authorization applications, and follow-up correspondence.
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by Line Manager.
  • Support clinical trials start up process.
  • To perform Lead CRA activities in selected studies.
  • Responsible for all aspects of site management as prescribed in the projects plans.
  • To conduct of pre-study, initiation, on-going and close out visits.
  • General On-Site routing monitoring.
  • Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • Close-out of clinical sites.

Senior Clinical Research Associate

Merck Lima, Peru
09.2006 - 09.2007
  • Conducted pre-study, start-up, routine monitoring and close out visits.
  • Designed tools and trained all staff for better and easier development of the trial.
  • Verified eligibility of subjects and consent procedure according to GCPs.
  • Reviewed source documents and source data verification for new patients, on treatment patients and follow up patients and approval of CRFs.
  • Reported the Serious Adverse Events; sent additional information, if requested for the NCI or INS (Peru).

Senior Clinical Research Associate

Eastern Cooperative Oncology Group Lima, Peru
05.2003 - 06.2007
  • Conducted pre-study, start-up, routine monitoring and close out visits.
  • Designed tools and trained all staff for better and easier development of the trial.
  • Verified eligibility of subjects and consent procedure according to GCPs.
  • Reviewed source documents and source data verification for new patients, on treatment patients and follow up patients and approval of CRFs.
  • Reported the Serious Adverse Events; sent additional information, if requested for the NCI or INS (Peru).
  • Advisory to accountant/administrator, nurses, office assistants, regulatory assistant and pharmacist.
  • Responsibilities spanned from the initiation through the study close out.

Board Directors Member

Non-Governmental Organization “Salud a Precio Justo” Lima, Peru
04.2003 - 11.2003
  • President of the Pharmacological Committee.
  • Managed and advisory of six drugstores within the country.
  • Developed and increased the medicines chart.
  • Negotiated with vendors about financial aspects.

General Manager

Pharmaceutical Wholesaler SR Lima, Peru
07.2000 - 04.2003
  • Managed personnel of all areas.
  • Negotiated with vendors and clients.
  • Managed financial aspects, payments, salaries, intakes, taxes.

General Manager

SBELT Medical Center & Clinical Laboratory Lima, Peru
07.1997 - 04.2003
  • Managed personnel of all areas.
  • Negotiated with vendors and clients.
  • Managed financial aspects, payments, salaries, intakes, taxes.

Chairman of the Board of Directors

GAZESA Import Lima, Peru
04.1996 - 07.1997
  • Led board meetings to discuss strategic direction and governance policies.
  • Facilitated communication between stakeholders and management for decision-making processes.
  • Evaluated organizational performance to ensure alignment with strategic initiatives.
  • Attended shareholder meetings to respond to questions about board activities or operations.
  • Reviewed financial statements, reports, and other documents prior to board meetings.
  • Oversaw corrective action plans to remedy structural, organizational and departmental issues.

Ophtalmology Assistant

Ophtalmologic Clinic Futuro Vision Lima, Peru
10.1995 - 06.1997
  • Primary attention of patients.
  • Refraction procedures.
  • Computarized campimetry.
  • Tonometry.
  • First assistant in surgeries.

Education

Clinical Trials Evaluation -

National Institute of Health – Health Research and Innovation Direction
Lima, Peru
12.2024

Project Management Certificate Program: The Kerzner Approach to Project Management Excellence - Management

International Institute For Learning, Inc.
New York, USA
09.2015

Medical Doctor -

National University “San Luis Gonzaga de Ica” School of Medicine
Ica, Peru
01.1995

Fellowship in Clinical Research with mention in oncology -

National Institute of Neoplasic Diseases (INEN) – Cayetano Heredia Peruvian University
Lima, Peru

Management and Hospital Administration -

Superior Institute "Jose Carlos Mariategui"
Lima, Peru

Management and administration of workers and services of health care -

Superior Institute "Jose Carlos Mariategui"
Lima, Peru

Skills

  • Accustomed to work under pressure
  • High emotional intelligence
  • Good listener
  • Open to learn from mistakes
  • Innovative with new technologies
  • Social media
  • Digital marketing
  • Design new tools
  • Collaborative project management
  • Team builder
  • Applied analytics
  • Data analysis
  • Collaboration
  • Integrity
  • Clinical trial management
  • Regulatory compliance
  • Project management
  • Quality assurance
  • Team collaboration
  • Effective communication
  • Problem resolution
  • Preparing reports
  • EMR charting
  • Time management
  • Leadership qualities
  • Multiple priorities management
  • Collaborative teamwork
  • Customer relationship management (CRM)
  • Strategy development
  • Verbal and written communication
  • Conflict resolution
  • Cross-functional teamwork
  • Complex Problem-solving
  • Workflow management
  • Adaptability and flexibility
  • Computer skills
  • Issue troubleshooting
  • Practice management
  • Research
  • Customer interaction
  • Customer engagement
  • Process improvement
  • Work Planning and Prioritization
  • Project reporting
  • Client engagement
  • Patient evaluation
  • Issue resolution
  • Meeting scheduling
  • Creative problem solving
  • Product knowledge
  • Client relationship management

Affiliations

  • Peruvian Medical College, 04/01/95, 28659
  • Scientific Association of Barraquer Institute of Barcelona – Spain, 01/30/97
  • CTEP, 07/01/05
  • NCI – USA, 38785

Language Capabilities

Born language, Advanced written and spoken, Intermediate spoken and written

Us Visa

B1/B2

Personal Information

  • Date of Birth: 04/27/67
  • Driving License: F10314300

Publications

  • PERU: Experience with Eastern Cooperative Oncology Group, Jorge Leon, MD, Tatiana Vidaurre, MD, Alfredo San Martin, MD, Carlos Vallejos, PhD., ECOG update, 3, 2, Summer 2006, 4
  • Clinical Research – The Best of 2023, Biomedical Journal of Scientific and Technical Research, 57, 4, 07/03/24, 07/15/24, Alfredo San Martin, Senior Regulatory Specialist Principal Clinical Research Associate, Resolution Latin America Peru Peruvian Medical College, 28659, Peru, 10.26717/BJSTR.2024.57.009025

Therapeutic Experience

  • Oncology (Breast Cancer, Promyelocytic Leukemia, Chronic Myeloid Leukemia, Lung Cancer, Head & Neck Cancer, Colon Cancer, Acute Myeloid Leukemia, Multiple Myeloma, Pancreas Cancer, Hepatocarcinoma, Carcinoid syndrome)
  • Endocrinology (Dyslipidemias, Acromegaly)
  • Rheumatology (Arthritis)
  • Infectious (HIV, Fungi)
  • Pulmonology (IPF, Asthma, COPD, Pneumonia)
  • Neurology
  • Cardiology
  • Nephrology
  • Immunology
  • Pharmacovigilance studies
  • Studies Phase I, II, III and IV

Other

  • Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Remote Data Capture (RDC version 4.1 and 4.5)
  • Medidata Rave
  • EDC 4.6

Language Capabilities

Spanish
First Language
English
Proficient (C2)
C2
Portuguese
Elementary (A2)
A2

Certification

  • Peruvian Medical College N° 28659

Timeline

Principal Regulatory Affairs & Study Start Up Associate

Resolution Latin America Peru
07.2024 - Current

Principal CRA / Regulatory Specialist

Resolution Latin America Peru
07.2021 - 06.2024

Clinical Research Associate III (SWAT Team)

PRA Health Sciences
05.2021 - 07.2021

Country Manager – HHCC (Home Health Country Coordinator)

MDE Services Group Limited
10.2020 - 04.2021

Project Manager – Sr. CRA

Peruvian Clinical Research
08.2019 - 09.2020

CEO / Project Manager / Clinical Research Advisor

SM Global Group
09.2016 - 07.2019

Grants Manager Central Group Member

AstraZeneca, Peru
09.2014 - 08.2016

Senior Clinical Research Associate

AstraZeneca, Peru
09.2014 - 08.2016

Senior Clinical Research Associate

Covance Lima, Peru
06.2007 - 04.2014

Senior Clinical Research Associate

Merck Lima, Peru
09.2006 - 09.2007

Senior Clinical Research Associate

Eastern Cooperative Oncology Group Lima, Peru
05.2003 - 06.2007

Board Directors Member

Non-Governmental Organization “Salud a Precio Justo” Lima, Peru
04.2003 - 11.2003

General Manager

Pharmaceutical Wholesaler SR Lima, Peru
07.2000 - 04.2003

General Manager

SBELT Medical Center & Clinical Laboratory Lima, Peru
07.1997 - 04.2003

Chairman of the Board of Directors

GAZESA Import Lima, Peru
04.1996 - 07.1997

Ophtalmology Assistant

Ophtalmologic Clinic Futuro Vision Lima, Peru
10.1995 - 06.1997

Clinical Trials Evaluation -

National Institute of Health – Health Research and Innovation Direction

Project Management Certificate Program: The Kerzner Approach to Project Management Excellence - Management

International Institute For Learning, Inc.

Medical Doctor -

National University “San Luis Gonzaga de Ica” School of Medicine

Fellowship in Clinical Research with mention in oncology -

National Institute of Neoplasic Diseases (INEN) – Cayetano Heredia Peruvian University

Management and Hospital Administration -

Superior Institute "Jose Carlos Mariategui"

Management and administration of workers and services of health care -

Superior Institute "Jose Carlos Mariategui"

Similar Profiles

CREATE PROFILE
Alfredo San Martin