Medical Device
Resume:
Alejandra Ramírez Santiago, MD, CCRA
Valencia, California, 91355
E-mail: ********@*******.***
*********.*******.********@*****.***
Cellular telephone: 646-***-****; home phone: 661-***-****
Summary:
Over 5 years of experience in a variety of management and staff positions within the medical device industry (Class II and Class III), contract research organizations (CRO) and pharmaceutical industries.
Graduated MD with postgraduate studies in Internal Medicine, pharmaceutical sciences and clinical research
Certified Clinical Research Professional by the Academy of Clinical Research Professionals (ACRP)
Excellent management skills, and extensive experience in clinical affairs, clinical trial managing, GCPs, quality systems under ISO 13485 and ISO 14155, auditing, regulatory affairs and compliance
Hands-on experience in clinical monitoring, site selection, investigator selection, protocol design, investigator brochure development, CRF design, authorship of device dossiers and regulatory submissions (510K, IDE, PMA, COFEPRIS submissions, EMeA submissions), direction inserts, statistical techniques, validation testing, preclinical studies
Effective leader and mentor, fast learner and committed professional
Key Accomplishments:
Developed and implemented Standard Operating Procedures for the Clinical Affairs area
Hosted successful Notified Body Certification audit in ISO 13485
Hosted successful FDA and COFEPRIS Audit on Clinical Sites
Provided clinical and end user input for the engineering R&D and product manufacturing resulting in significant device improvements
Prepared and successfully gained 510(k) approvals for various indications for use for medical devices while working in a CRO.
Prepared IDE and PMA applications for the Medical Device Industry
Prepared and successfully gained Regulatory Body approvals in Latin-America and Austria.
Successfully developed the business plan to constitute Alandra Medical S.A.P.I Mexico as a CRO specialized in Medical Devices
Prepared and successfully submitted Clinical Evaluation Reports to allow the company to maintain CE mark
Prepared and successfully develop a Post Market Clinical Follow up as part of the company CE mark submission.
Successful interaction with principal investigators, clinical sites and key opinion leaders.
Work Experience:
Palyon Medical Corporation (USA, Santa Clarita, California) March 2012-present
Clinical Affairs Manager, Medical Liaison and Medical Officer:
The company designs and develops new technology in the field of implantable medical devices, interventional chronic pain management, and neuromodulation. My accomplishments and responsibilities are:
Authorship and implementation of the Clinical Affairs department SOPs
Clinical plans design of an IDE study with an active implantable medical device (Class III) and Post-Market follow-up within the European Union
Clinical evaluation reports authorship to maintain CE mark
Study management of the different protocols under our IDE and in the EU
Direct participation as an MD (end user) in product requirements, validation and testing
Multicenter study management
Medical liaison with principal investigators, investigational sites and key opinion leaders
Authorship of essential study documents, i.e., Investigator Brochure, Study Protocols, ICD, etc.
Authorship of Clinical Evaluation Reports, Periodic Safety Reports, interim reports, instructions for use and device dossiers
CRO and CRAs management
Support the R&D team on design requirements, testing, design inputs and outputs, and hazard analysis for our products
Authorship of Preclinical studies
Authorship and implementation of the Post-Market Clinical Follow-Up in the European Union for maintenance of CE mark
Palyon Medical Corporation (USA, Santa Clarita, California) August 2011-March 2012
Clinical and Regulatory Affairs Consultant:
I provided regulatory and clinical consultant services to the company while in Mexico City in a very successful and effective way that ended in my being offered a position with them in the USA. My key accomplishments during this time were:
Clinical plans design for an IDE study and a Post-Market follow-up within Mexico
Protocol design
CRF design
Investigator Brochure design
Regulatory strategy for the conduction of clinical plans in Mexico, Guatemala and Chile
Direct participation (as an MD) in product requirements, validation and testing
Medical liaison with PIs and KOLs in Latin-America
Support the R&D team on design requirements, testing, design inputs and outputs, and hazard analysis for our products.
Authorship of Preclinical studies
Alandra Medical (México City, México) Jan 2011-Feb 2012
Contract Research Organization and Medical Devices (One year contract) - incubator/accelerator
Clinical Trials Sr Manager
My function during my one year contract in this position included the following activities:
Protocol design for clinical and pre-clinical trials
Design and conduction of clinical and preclinical trials with company’s own technology and with foreign Sponsors
Regulatory submissions, Regulatory strategy definition for Class III and Class II devices such as:
o Orthopedic Arm Prosthesis
o Implantable Infusion pumps
o Gynecologic radio frequency ablation device
o Drug eluting stents
o Drug Delivery Systems
o Bone grafts
o In Vitro Diagnostics
o External occipital electrodes
o Lacrimal gland implantable stimulators
IRB submissions to several clinical sites
Site and Clinical Investigator selection:
Pre-study monitoring visits
Site initiation visits
Study monitoring visits
Study monitoring reports
Supervision of 5 junior CRAs
Study and project management
Safety reporting
Query resolution
Study budget planning
Study termination visits and Study closure
Coordination of data analysis and clinical data handling
Biostatistical plan design
Business opportunities prospection
Business plan to develop a full service CRO specialized in Medical Devices
Medical Writing (for Regulatory documentation and academic papers).
Strategic Alliances coordination
Glaxo Smith Kline: (México City, México) Feb –May 2009
Clinical Research Associate (CRA) (Temporary 3 month assignment)
Clinical monitoring of a Research Study, two arms, randomized, double-blind, multi-center, multi-national study, with 3000 enrolled subjects in México City, to evaluate the efficacy and safety on pediatric population (0 to 36 months old) of an Influenza vaccine manufactured by GSK vs an Influenza vaccine commercialized by other pharmaceutical company. Beside the monitoring task, part of my functions included:
Training of site clinical staff
Preparation of sites for possible internal audit by regulatory agencies
Preparations and conductions of investigator’s meetings
Review and correction of translations of protocols and amendments
SAE reporting, SUSAR’s reporting and pharmacovigilance of commercialized products
Study management of a multicenter trial
Supervising 3 Jr. CRAs
Pfizer: (Mexico City, Mexico) June-Sept 2008.
Clinical Research Associate (CRA) Project contract
Clinical monitoring of phase II-IV clinical drug studies, primarily on inflammation and infectology areas (HIV); assessment and selection of research sites and principal investigators accordingly to Pfizer s protocol needs and policies; training of site staff on GCP and specific protocol procedures, as well as FDA and local regulations; Site initiation and closeout visits; preparation and conduction of investigator meetings; preparation of sites for possible audits in compliance with Pfizer s inspection readiness policies. Supervision and correction of translations to Spanish of clinical protocols and amendments, and adequacy of language and requirements according with country specific regulation and IRB reviews (if applicable); COFEPRIS submission of new protocols, and amendments, as well as reports of Serious Adverse Events (SAE s) and Suspected Unanticipated Adverse Events (SUSARS).
Corporate Medical Tower: (Mexico City) Jan 2007-Jun 2008
Devices and Hospital Services (Per project contract)
Director of the area of Clinical Research and Clinical Research Coordinator (CRC)
Coordinated several research protocols in according to National Regulations, FDA Regulations and GCP, for example:
o Feasibility Research of a Medical Device applied to a cosmetic treatment (Phase IIb Study)
o Pivotal research of a permanent contraception device (Phase III-IV study)
o Pivotal Study of a laparoscopic surgery clamp
Create and implement the SOP manual of the Hospital Research Coordination
Document and organize both protocols information for an FDA audit.
Coordinate all the areas of the Hospital involved in the protocol development to ensure the correct performance of studies in accordance to the protocol study manuals, local and international regulations and GCP
Handle and coordinate all hospital personnel who make up the research team
Assist the Principal Investigators in recruitment, selection and follow-up of study subjects
Create and complete source documents and CRF’s in accordance with Good Clinical Practices (GCP), as well as filling out and updating clinical charts of the subjects participating in studies
Study Management on site
Private Medical Practice: (Mexico City) Apr 2004-Jan 2007
Health Care Services
I had a private practice, renting an office in Mexico City. My practice was specialized in Family Medicine and Internal Medicine. I also had a temporary contract with the Instituto Mexicano del Seguro Social (IMS) and with ISSTE making night shifts on the Emergency Room.
Education Certifications and Training
Graduated MD (Medical Doctor):
By the Universidad Nacional Autónoma de México, awarded the Gabino Barreda Medal to the academic merit as a result of obtaining the highest score of my generation
Postgraduate Studies:
• Master’s Degree in Pharmaceutical Sciences. Master’s in Pharmaceutical Sciences course offered by the UAM Xochimilco in Mexico City. This master’s addresses the following disciplines: Bio pharmaceutics (bioequivalence and bioavailability), pharmacometrics, statistics, research methodology, clinical research, pharmacovigilance, pharmacoeconomics, basic pharmaceutical research, biomolecules, therapeutic, national and international regulation regarding clinical research, national and international regulations for the registration and approval of new molecules and generic drugs, pharmacogenomics, research of therapeutic targets, etc.
• One year of specialty studies in Internal Medicine at the General Hospital Gaudencio González Garza CMN La Raza, during which I obtained skills and experience related to the care of hospitalized patients in cardiology, internal medicine, intensive care, nephrology, peritoneal dialysis, dialysis, neurology, oncology, dermatology, neurology, emergency and outpatient.
Certifications:
• ACRP CCRA Certification, granted in March 2012.
• Certified Course on Clinical Monitoring, given by the Universidad Nacional Autónoma de México. Currently taking this course.
• Certified course on ISO 141385 and ISO 9001
• Protection of Human Research Subjects given by The Collaborative IRB Training Initiative (CITI)
• “Comprehensive Monitoring of Medical Devices”, given by Barnett Educational Services, in August 2007, with 22.5 hours of continuing education credit.
• Member of the Academy of Clinical Research Professionals (ACRP), certified.
Computing Skills:
Windows 98, Me, 2000, XP Professional, Vista; Microsoft Word, Microsoft PowerPoint, Microsoft Access, Microsoft Excel, Microsoft Front Page, Outlook Express, Internet Explorer, HTML, SPSS Statistical Software, Microsoft Project, Microsoft Visio, Jabref, experience using CTM software on Oracle platforms.
Additional Languages:
English: Bilingual
Spanish: Native Language
French: Basic knowledge
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