Project Manager Clinical Research

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Resume Confidential

E-mail: abnojj@r.postjobfree.com

CLINICAL AND SCIENTIFIC RESEARCHER - DESIGN AND IMPLEMENT PILOT-

FEASABILITY AND PIVOTAL STUDIES - CLINICAL TRIALS EXECUTIVE

PHYSICIAN NETWORK DEVELOPMENT- LEADERSHIP DECISIONS AND PROJECT

DELIVERY- STRATEGY PLANNING

FDA COMPLIANCE AND EUMA GUIDELINES

MEDICAL PRODUCT SAFETY COMPLIANCE

BIOMARKER ROAD MAP DEVELOPER

Education:

MD Diploma on Medical Compression and Sclerotherapy, University Pierre-Marie Curie / Salpetierre

Hospital, Directors AC Benhamoud, MD, JP Benigni, MD, 2005.

MD: Internship Vascular Surgery, Bellvitge Hospital, Director Eduardo Castells Cuch, MD, 1998-2000.

MPH: Master of Public Health, John Hopkins University School of Hygiene and Public Health/ Barcelona

University, 1990-1992

MDOpht Specialty in Ophthalmology, Barcelona Autonomous University, 1986

Ph.D. Doctor Physiology in Medical Science, Barcelona Autonomous University, 1983-1986

MD Medical Doctor, Barcelona Autónomos University, 1983

Other Degrees

Vascular Ultrasound Specialist (2004), ATI School of Health, Miami, Florida

Clinical Research Specialist (2004-2007)). University of North Carolina, University of Washington, University

of Miami

Teaching Positions

Barcelona University, Ophthalmology Assistant Professor (1984-1987)

University of Miami, Faculty Professor Chairman Vascular Laboratory (2004-2008)

ATI School of Health, Faculty Professor Vascular and Echocardiography (2004-2006)

Institute of Allied Medical Professions, Faculty Professor Chairman Vascular (2006-2008)

Selected Achievements:

• Design and Implement Pilot- Feasibility-Pivotal and Clinical Trials Monitoring Clinical Trials in

accordance to GCP-ISO compilation, presentation IRB national and international. SOP’s development

and implementation.

• Pre clinical and clinical Biomarkers discoveries and diagnostic tools development

• Design UAT Scripts for Electronic Data Management System for Clinical Trials

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• Prepare presentation for NIH and DoD grants for clinical studies, HRPO review

• Prepare IND for new drugs a submission to FDA prior clinical trials, and NDA after clinical trials for

marketing approval. Documentation for submission of 510(k) on devices and drugs to FDA and EMA

• Design and Coordinate a complete cardiovascular product evaluation in terms of efficacy,

effectively, user’s compliance and hemodynamic influence over several cardiovascular conditions and

Chronic Vein Insufficiency (CVI). Proposals for products improvement, and new products design.

• Proposal and development on alternatives to traditional diagnostic for cardiovascular, vascular

and Traumatic Brain Conditions

• Pharmacovigilance: Adverse Events (AE) and Serious Adverse Events (SAE) narrative writing,

data entry, tracking, coding and case processing premarketing and postmarketing

• Effective medical product safety programs.

• Interventional arterial stems for aneurism, and graft, devices for embolectomy

• Develop and improve a new sclerotherapy delivery slcerosing agent system to produce

homogeneous distribution on the endothelium of the treated vein.

• Described a new technique for liquid and foam sclerotherapy to improve good results and decrease

side effects.

• Developed line of diagnostic products for vein hemodynamic evaluation with stockings and bandages

delivering compression (interface measurement) and lymph edema diagnosis procedures.

• Interpret and evaluate the measurement of PRO instruments, and protocols (SF-36).

EXPERIENCE:

University of Florida Present

Sid Martin Biotechnology Incubator Center for f Innovation Research, Banyan Biomarkers Inc.

President Garry Ascani

Clinical Studies Manager,

Biomarkers discoveries and diagnostics tools in Cardiovascular, Neurological, Gastrointestinal, Cancer

-Protocols, SOPs, sites and physicians network, PK-PD (time points, samples tracking, assay) clinical

monitoring, data capture (eCRF), WOC analysis, presentation, R&D and PR interaction, Pilot, Feasibility and

Pivotal studies draft, IRB presentations, USAMRMC ORP HRPO and DoD presentation.

National and International scientific network cooperation on Biomarkers discoveries (USA, Italy, Hungary,

Sweden).

-Data management medical analysis regulatory reporting for AE and SAE: reports and case processing, review,

regulatory reporting assessment, electronic Adverse Event Reporting (IRB, WIRB, HRPO).

-Validated 21 CFR Part 11 electronic management

-FDA – EMS Guidance In Vitro Diagnostic Multivariate Index Assays

Electronic Data Management System, design and release electronic data management system for clinical

trials (unclassified document available), eCRF forms design (unclassified document available), monitoring

system for data management and reports creation, design UAT scripts for electronic data management.

Clinipace- Tempo, advisor and monitor for clinical trials management on samples tracking and time points

applications.

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University of Miami, Leonard M Miller School of Medicine, The DeWitt Daughtry Family Department of

Surgery Department of Vascular Surgery, Vascular Screening Program “Betty and Norman F Levy

Foundation”

Grant and Contract Position January 2006- November 2008

Director Vascular Screening Program –

Teaching Vascular Surgery Training

Congestive Heart Failure Clinic Vascular Ultrasound

Management

- Draft program brochures, and protocols

- Equipment for program

- Supplies and accountability

- Schedule and participants

- Coordinate on site activities

- Data recollection, processing and presentation, electronic data (including image processing files)

design eCFR forms.

Patient Care

- Diagnostic Cardiovascular affection

- Medical or Surgical management

- Physicians Training

- Surgical Evaluation and follow up

- Preparation for submission of Periodic Safety Update Report and Adverse Drug Experience Report for

different vascular devises studies and drugs.

- Troponin/ECO relation diagnostic

CRO - Doctors Research Network

Jason R Hanft, DPM, FACFAS

Maria S Suprenant, DPM, FACFAS December 2005- January 2006

Coordinator Clinical Research (Part time Contract)

- Management of clinical trials, patients screening and recruiting, consent form, prepare Clinical

Report Form transferring data from exam notes, drug accountability, manage laboratory results

for PK-PD

- Conducted trials and participated in the clinical operations.

- FDA’s good Pharmacovigilance Practices guidelines

Clinical Trials

- Genentech, Inc. Phase II, double blind, randomized, placebo-controlled study to assess the effect of

topical recombinant Human Vascular Endothelial Growth Factor (Telbermin) for induction of healing

of Diabetic foot ulcers.

- ApoPharma, Inc. Pivotal study to evaluate the efficacy and safety of Dermal-living skin replacement

(Dermal-LSR) in the treatment of chronic Diabetic foot ulcers.

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- Intercytex, Phase III, prospective multicenter, double blind randomized placebo controlled trial to

evaluate the safety and efficacy of ICXP007 with four layer therapeutic compression for the treatment

of non-infected skin leg ulcers, due to venous-insufficiency.

VeinRx, Inc

Scott Jahrmarkt, President

Brett Naglreiter, Vice-President Research and Development

Contract Position Consultant Scientific and Medical Affairs-International Relations 2006

- Alfa Team leader, development of strategy and different research, to improve safety and efficacy

on the delivery system method for the slcerosing agent to be use on the sclerotherapy procedure

liquid or foam.

- Efficacy and Safety reviewer, comparing competitors endovenous ablation procedures results

like Ultrasound Guide Sclerotherapy, Radiofrequency, Laser, others similar delivery system,

preparing a metha-analize of the world wide existing papers and publications defining the

variables of influence on the results and define the strategy to succeed. Product safety

management plan, ISO quality audit certification, Quality system regulation guidelines (QS

regulation) and Medical Device Reporting (MDR).

- Elaborate a sclerotherapy procedure technique, to minimize the concentration and vo. lumen

of the slcerosing agent delivered liquid or foam, maximizing the effect over the vein to treat its

tributaries and collaterals branch and perforator’s vein in the area, looking always to succeed,

with the reduction on the numbers of re-interventions and keeping good results over long periods

of time.

- Audited on-going clinical research, update clinical research documentation to comply with

GCP, SOPs, EMA, IRB, Consent Forms, FDA, NIH, ISO, recommendations and templates.

Review of protocols and budgets of clinical research and development, made recommendations

and changes.

- Develop a local and international key opinion leader’s support network, supporting the

efficacy/cost/effectively of sclerotherapy with the company delivery system for the slcerosing

agent in relation with the Ultrasound Guide Sclerotherapy, Radiofrequency, Laser and Surgery

- Search new developments in the field of sclerotherapy agents, identifying supply sources,

analyzing cost-manufacture process, exploring safety and efficacy of their components, in short,

intermediate and long term effect. The behavior with different delivery systems and structural

changes.

- Interaction with marketing in market research study for product development and post

marketing safety report of delivery system and sclerotherapy agents.

BSN-JOBST

Mauricio Bellicu, President

Dean Bender, Vice-President Research and Development

Scientific & Clinical Affairs Manager (Part time Consulting) 2005-2006

- Clinical Assessment, prepare the clinical assessment and clinical references for CE marked products

in phlebology, lymphology and wound care. Helped with the development process of new products

with clinical evidence and support for 510(k) –FDA submission.

- Package Insert, reviewed inserts before marketing.

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- Medical Literature reviewed and presented medical support statements. Designed and implemented a

clinical support library after reviewing 15,000 articles and papers on phlebology and lymphology to

serve as a Toolbox of reference articles to support the company’s clinical-marketing strategy.

- Scientific and Clinical Statements, support all new product ideas through the Stage Gate process and

Research & Development process in new fiber, technology, diagnostic and therapeutic equipment, and

new product applications.

- Audited on-going clinical research, update clinical research documentation to comply with GCP,

SOPs, EUDRACT, IRB, Consent Forms, FDA, NIH, ISO, recommendations and templates. Review of

protocols and budgets of clinical research and development, made recommendations and changes.

- Developed a physician network, base on different global professional organizations such as

American Venous Forum, American College of Phlebology, American College of Surgeon, American

Academy of Dermatology, French and German Society of Phlebology, European Lymphedema

Group, International Compression Club, Union International of Phleboloby, European Venous Forum,

European Wound Management Association, Pan American Association of Phlebology and

Lymphology, National Lymphedema Network, American Association of Diabetes Educators.

Solicited suggestions and recommendations from global key opinion leaders for products improvement

or new products development in the areas of phlebology, lymphology and wound care.

- Proposal and design of clinical research utilized global physician network, global health care

institutions, international universities and colleges to conduct market research, clinical studies, propose

and draft protocol and budget, sites identification, enroll health care professional participants. Ensure

compliance with local government regulations (USA-EU). Establish hypothesis, variables of cases,

measurement methods, evaluation and scoring, data recollection, data analysis, presentation,

publication and distribution.

- Recommendations for design and manufacturing, base on assessment of clinical studies,

incorporating new technology in medical compression stockings, bandages, and devices with

application in phlebology, lymphology and wound care.

- Scientific and Clinical Symposium development designed and developed global scientific meetings,

speaker invitations and topics on Phlebology, Lymphology and Wound Care.

- Prepublication Book Review, chapter on compression. “Sclerotherapy “, Mitchell P Goldman, MD.

Clinical Research Organization (CRO) – Vision of America, Inc.

Owned by Capital Search Advisors - TB Capital Holdings

Randall Evans, President

Position: Director of Scientific Research Investment 2000-2004

Companies contracted and Clinical Trial Executive for:

1- Nuvelo, Phase I-II, Arterial Occlusive Diseases, Drug: Alfimeprase.

2- Bristol-Myers Squibb, Phase I, Kawasaki Disease, Drug: Sestamibi.

3- Sanofi-Aventis, Phase I-II, Vein Thromboembolism, Drug: Enoxaparin sodium.

4- Clinical Therapeutics, Phase I, Coronary Disease-Heart Valve Disease, Drug: Ethyl pyruvate.

5- Ortec International, Interventional, Venous Insufficiency-Leg Ulcer, Device: Bilayered Cellular

Matrix (OrCel).

6- National Healing Corporation, Phase I-II, Venous Ulcer, Procedure: Autologous Platelet Gel

7- Intercytex, Phase I-II, Leg Ulcer, Drug: ICXP007

8- Boston Scientific, Interventional, Abdominal Aortic Aneurysm, Device: ENOVUS AAA Endograft,

• Participated in the management of clinical studies

• Elaborate site’s amendments for Protocols.

• Conducted trials and participated in the clinical operations.

• Gained experience in relevant clinical research, design, analysis and reporting.

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• Gained knowledge of the procedure development process, both domestically and

internationally.

• Learned to recognize safety and efficacy data trends (21 CFR Part 11), AE and SAE case

processing

• Responsible for managing the submission of NDA’s, conduct completeness, scientific accuracy

and review of submissions. Liaise with the review branches of FDA throughout the review

process of submissions and represent Regulatory at FDA meetings (pre-NDA Also served as

lobby group contact and US Agent Representative.

Clinical Research Organization (CRO) - The New Jersey Research Institute, Inc

John A Lucca, MD, President

Alex Arias, Vice-President Research

Position: Senior Clinical Project Manager 1994-1998

• Perform feasibility studies to assess the targeted market, consumer needs and probability of

success of each clinical trial Clinical Project Head and Senior Clinical Research responsible for

the elaboration.

• Development and implementation of clinical research, drafted clinical and surgical trial

protocols, participates in the management of clinical study (plans, consent, newsletter, report,

abstract and manuscripts, design and selection of endpoints, timelines, personnel and budget,

safety and data, training programs) proposed work.

• Participates in conduct the trials and the clinical operations in NDA and ANDA multi-site.

Clinical sections of IDEs, PMAs, 510Ks, CRFs. Experience in relevant clinical research, design,

analysis and reporting. Scientific achievement (author of publications). Knowledge of drug

development process domestic and international. Ability to recognize safety and efficacy data

trends.

Investigator site qualification, IRB, FDA requirements for managing the submission of IND’s

and NDA’s, conduct completeness, scientific accuracy and review of submissions, GCPs, ICH

SUMMIT CORPORATION

Excimer Laser Applications

Ronald M. Glassman, MD, Principal Investigator,

Jackie Rivadeneira, Chair Project

Position: Project Coordinator 1992-1994

The Excimer Laser Study: Two years of product use in Refractive Surgery for Myopia, Astigmatism and

Hyperopia, and Photo therapeutic use”. Interventional study, data collection, analyzes presentation. Liaise

with the review branches of FDA throughout the review process for submissions and regulatory meetings.

Clinical Research Associate (CRA) 1986-1989

Position: Independent Contractor

Prazosin. (Drug), Phase I-IV, IRB recompilation and presentation, NDA submission, Pfizer Laboratories,

1986

Plate-Lens accommodative of PMM (Device). Interventional, IRB recompilation, 510 K submission,

Meditec, Corp, 1987

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Specular Microscopy, (Device). Device, Interventional, IRB recompilation and presentation, 510 K

submission, Keeler- Konan Corp. / Alcon Surgical Laboratories, October 1988.

Nd-Yag Laser, (Device). Interventional, IRB presentation and evaluation, Trial Monitor, Nidex Corp,

September 1989

Member Professional Associations

- American College of Phlebology (USA)

- American Academy Vascular Sugerí (USA)

- French Society of Phlebology (FRANCE)

- Royal Society of Medicine (UNITED KINGDOM)

- Real Academia de Medicina y Cirugía (Barcelona, SPAIN)

- Colegio Oficial de Médicos de Barcelona y Baleares SPAIN)

- Union International of Phlebology (GERMANY)

- Pan American Association of Phlebology and Lymphology (BRAZIL)

- European Wound Management Association (GERMANY)

- Washington University, Epidemiology and Public Health Department (ERIC) (USA)

- University of North Carolina Office of Clinical Trials (USA)

- Center for Professional Innovation & Education on Clinical Research (CfPIE) (EUROPEAN

UNION)

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