Senior Clinical Research Professional
Resume:
Full Name:
Dr. Juan Reyes, DVM, MS, CCRA®
Location:
Piscataway, NJ 08854
Career:
Associate Director, Clinical Research - Global Project / Study Management
Country of Residence:
US – US Citizen
Cell:
Email:
acwmtr@r.postjobfree.com
LinkedIn:
https://www.linkedin.com/in/juanreyesdvm
Certified (CCRA®) Clinical Researcher 10+ years of global R&D experience
Dr. Reyes (DVM) oversees project teams representing both the sponsor and clinical delivery team. In the recent role, Dr. Reyes responsibilities included but were not limited to managing the operational aspects of projects to meet contractual requirements in accordance with SOPs, policies, and practices; ensuring delivery of study quality and patient recruitment - driving site compliance; and leading, mentoring and training of the clinical operations team. In previous roles, Dr. Reyes oversaw, managed, co-monitored, and monitored global and domestic interventional (registry) clinical studies: phase I, II, III, IV, observational / non-interventional, and is experienced in the following therapeutic areas: Cardiovascular (CHF), Respiratory Infections (Adults), Asthma (Pediatrics), Infectious Disease (Anti-rabies Vaccines Production for Clinical Use ex-US), Neurology (CNS: Pain Management [Dental, Headache], HEOR), Burn Wounds Repair (Anti-infective, Pain Management), and Oncology (Pre-clinical: Testing of Radio-labeled Monoclonal Antibodies in-vivo/in-vitro), Medical Device and Electro-surgical Equipment for Arthroscopic and Open Surgery (Absorbable and Metallic Suture Anchors) with Imaging, H-Device for Meniscus Repair, Bipolar Scissors, Bone Remodeling Electrosurgical Equipment Prototype), and Tobacco Harm Reduction. Dr. Reyes oversaw the planning, hosted, and participated of several Sponsor and Investigator`s Meetings worldwide: LATAM (Argentina), EU: two [2] in Czech Republic, and USA (as Associate Director Clinical Protocol Manager and as Monitor). He has direct experience with clinical study site monitoring in North America (Canada, Mexico, and USA). He also has direct experience driving the development and writing of Essential Documents (IBs, Protocols, ICDs), development of CRFs, Communication and Monitoring Plans, evaluation of Site and TMF/eTMF and quality assurance audits, resolution of CAPAs, and Risk Mitigation Plans. Liaising with Customer and External Vendors (e.g.: CRO, IRB/EC, Imaging, DM, and Labs).
Formal Educational History
Institution Name, Country
Education Level/Degree
Area of Study
Completion Status
Rutgers University, New Brunswick, NJ
Professional Development (Certificate)
Project Management
Completed
Eastern Connecticut State University, Willimantic, CT
Professional Development (Certificate)
Project Management
Completed
Mercer County Community College, West Windsor, NJ
Professional Development
(Certificate)
Clinical Research
Completed
PCAge, Certified Career IT Institute, Edison, NJ
Professional Development
(Network Engineer)
Network Engineer
Completed
University of Missouri, Columbia, MO
Master of Science (MS)
Animal Sciences (Nutrition)
Completed
Universidad Autonoma de Santo Domingo, DR
Doctorate (DVM)
Doctor of Veterinary Medicine
Completed
Employment History
Date of Employment:
05/2016 – 06/2016
Name of Employer:
Vaco Healthcare LLC / Quintiles, Inc.
Job Title:
Associate Clinical Lead Director
Key Responsibilities:
• Member of the core project team and partners with the Project Leader
• Ensured overall project meets delivery requirements.
• Ran large, multi-regional studies, with Lead Clinical Analyst (LCA) support.
• Managed the operational aspects of projects to meet contractual requirements and in accordance with SOPs, policies and practices.
• Represented clinical delivery with customer.
• Accountable for right subjects and right data to meet or contractual requirements.
• Collaborated with project leader and LCA to establish an integrated set of plans with CL to be ultimately accountable for results of the clinical team.
• Produced and distributed status, tracking and financial reports for the core project team, other functional groups and senior management.
• Tracked financial deliverables, reporting and invoicing on projects
• Ensured appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer. Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target and contingency plans are in place and deployed at trigger points.
• Worked toward the delivery of the project / program according to the quality management plan.
• Managed clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums.
• Approved final sites lists.
• Developed clinical protocol presentation from the CRO project team for face-to-face investigator meeting.
Date of Employment:
07/2013 - 04/2014
Name of Employer:
R.J. Reynolds, Winston Salem, NC
Job Title:
Master Scientist, Clinical Studies
Key Responsibilities:
Project Management for Clinical Studies Division:
• Managed clinical studies under the FDA, company SOPs, and best practices to protect human subjects.
• Participated in the biannual updates of SOPs to prepare the final documents.
• Worked with in-house colleagues to prepare clinical process design and initiation of studies.
• Protected both: 1. Study subjects’ safety, wellness, and privacy. 2. Public health.
Date of Employment:
09/2010 - 03/2011
Name of Employer:
Yoh Services/Bayer HealthCare, Morristown, NJ
Job Title:
Senior Clinical Research Manager
Key Responsibilities:
Clinical Study Management:
• Led clinical study team comprised of, but not limited to Medical Affairs, Project / Study Management Department, Regulatory Affairs, Quality Assurance, Statistics Department, Data Management, Clinical Supplies and Clinical Study Monitoring departments, CROs project teams and study
vendors or providers - EDC, IVRS, laboratories, imaging.
• Managed the design and writing protocol, initiation, planning, execution and close-out process for 6-7 global, but mono-center fast paced and at different stages clinical PK and dental studies to test and develop iterations of OTC products for pain management - headache, dental.
Date of Employment:
09/2009 - 12/2009
Name of Employer:
Ximedica, LLC, Providence, RI
Job Title:
Senior Clinical Affairs Consultant
Key Responsibilities:
• Provided clinical project/study management and clinical study monitoring, for global and domestic clinical studies for the biotechnology, pharmaceutical, medical device, medical equipment, and CRO industries.
Date of Employment:
01/2008 - 08/2009
Name of Employer:
Pfizer, Inc., New London, CT
Job Title:
Associate Director, Clinical Protocol Manager
Key Responsibilities:
Clinical Study Management for the Inflammation Department:
• Led simultaneously three (3) separate global clinical project teams.
• Developed overall project strategies, with respective Risk Mitigation, leading cross-functional operational project teams to plan, conduct and close-out multiple RA global clinical studies within programs alignment and resources while maintaining high degree of Quality Assurance.
• Developed and performed Audit Preparedness Plan for 20+ global clinical studies, Clinical Studies Division, to ensure a high degree of quality assurance.
• Oversaw successful planning and execution of face-to-face investigator meetings for Latin America (LATAM): one (1) in Buenos Aires, Argentina, Asia and Europe: two (2) in the Czech Republic, and US: one (1) in Florida, US, as well as numerous virtual investigator meetings.
Date of Employment:
01/2007 - 05/2007
Name of Employer:
Adams Respiratory Therapeutics, Chester, NJ
Job Title:
Senior Clinical Study Manager
Key Responsibilities:
Clinical Study Management for Mucinex Seasonal Clinical Study:
• Managed CRO (TKL Research) clinical project team (one project manager and 16 senior clinical research associates) to design and writing protocol, initiation, planning, execution and close-out process for a 6-7 global seasonal clinical study to test Mucinex an OTC product - respiratory system.
• Performed development and writing of seasonal clinical study
protocol and investigator brochure (IB) for OTC products.
• Oversaw clinical study activities: start-up, recruitment, conduct, and close-out.
• Provided significant input (improvement) for established bi-annual SOP review.
Date of Employment:
01/2007 - 12/2012
Name of Employer:
Pharmaceutical Development Services, LLC, Lewes, DE
Job Title:
Senior Clinical Research Consultant/Owner
Key Responsibilities:
• Provided clinical project/study management and clinical study monitoring, for global and domestic clinical studies for the biotechnology, pharmaceutical, medical device, medical equipment, and CRO industries.
Date of Employment:
10/2006 - 12/2006
Name of Employer:
Aerotek/Schering-Plough, Kenilworth, NJ
Job Title:
Project Manager
Key Responsibilities:
• Short-term contract to retrieve and transfer regulatory packages corresponding to global clinical study to global central trial master file (TMF).
Date of Employment:
06/2004 - 07/2006
Name of Employer:
UnitedHealth Group / Sanofi-Aventis, Bridgewater, NJ
Job Title:
Clinical Project Manager
Key Responsibilities:
Clinical Study Management: Test Product: Telithromycin (Ketek®) Among Other Respiratory Rx Products:
• Oversaw contracted CRO and vendors (e.g.: Covance, IntraLinks, ePharma Solutions) on clinical project team activities that led to successful planning, conduct, and close-out of outsourced multi-center and multiple (10+) Key Opinion Leaders Investigator Initiated Trials (IITs) or Investigator Sponsored Trials (ISTs) to test anti-infective and prescription products for Respiratory System in adult and pediatric population.
• Led planning, planning, kick-off meeting, initiation (virtual Investigator Meetings with ePharma Learning) for multi-center KETEK clinical protocol.
• Developed and accounted for the expenditure of project/study budgets.
• Led the review of annual IND, CMC, IB annual updates, clinical study protocols, protocol amendments, informed consent documents of pharmaceutical products in development.
Date of Employment:
09/2002 - 06/2004
Name of Employer:
Orion Pharma, Inc., Florham Park, NJ
Job Title:
Senior Clinical Research Associate
Key Responsibilities:
• Clinical Study Management and Co-monitoring: Supervised and co-monitored with MDS Pharma Services Project Team. Administered the progress of Decompensated Chronic Heart Failure (CHF) REVIVE global clinical (registry) study, Phase 3, in Australia, Canada, and the US.
• Evaluated regulatory packs corresponding to clinical study sites for submission to Health Authorities, IRB and Ethics Committees.
• Evaluated quality assurance (audit reports) for the CHF study and provided recommended preventive and corrective actions, as applicable.
Select Accomplishment: Developed and executed Motivational Site Visit Plan to overcome Subject enrollment issue affecting the CHF clinical study.
Name of Employer:
Quintiles, Inc., Atlanta, GA
Job Title:
Clinical Research Associate
Name of Employer:
Kendle International, Inc.
Job Title:
Clinical Research Associate
Name of Employer:
Ethicon, Inc., Somerville, NJ
Job Title:
Assistant Scientist
Name of Employer:
Immunomedics, Inc. / Center of Molecular Medicine and Immunology
Job Title:
Laboratory Animal Tech., Immuno-Oncology
Clinical Trial Experience
Study Phase:
Phase 1 – Phase 4
Indication:
CNS (Alzheimer's Disease, Schizophrenia), Systemic Sclerosis, Heart Failure, Rheumatoid Arthritis, Respiratory, Dermatology, Infectious Disease, Oncology (Early Drug Discovery), Orthopedics.
Products:
Biologics, Pharmaceuticals, OTC, Medical Devices, Electro-surgical Equipment, Consumer Products (Women’s Health, Tobacco Harm Reduction).
Publications, Doctoral Thesis
Effect of Supplemental Yeast Culture in Sow Gestation and Lactation Diets on Apparent Nutrient Digestibilities and Reproductive Performance through One Reproductive Cycle - Master Thesis, Journal of Animal Science, 1995, 73:1741-1745.
Comparative Study of Natural Mating vs. Artificial Insemination in Dairy Cattle - Doctoral Thesis.
Certification
Certified Clinical Research Associate (CCRA®), 03/2012 – 05/2018.
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