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Summary

As a Clinical Lead, Dr. Reyes oversaw core project team representing clinical delivery with the customer.  Dr. Reyes’ current responsibilities included 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 has overseen, managed, 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, H-Device for Meniscus Repair, Bipolar Scissors, Bone Remodeling Electrosurgical Equipment Prototype), and Tobacco Harm Reduction.  Dr. Reyes has overseen 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.  Dr. Reyes is a Certified Clinical Research Professional (CCRA®) with 10+ years of extensive (Clinical and Pre-clinical) International and Domestic Leadership experience, and is versed in using complex clinical trial management systems for daily clinical operations.

Experiences

Past Experience

  • Associate Clinical Lead Director Piscataway Township, NJ, United States
    May 2016 --- June 2016

    1. Member of the core project team and partners with the Project Leader
    2. Ensured overall project meets delivery requirements.
    3. Responsible for running large, multi-regional studies, with Lead Clinical Analyst (LCA) support.
    4. Managed the operational aspects of projects to meet contractual requirements and in accordance with SOPs, policies and practices.
    5. Represent clinical delivery with customer.
    RESPONSIBILITIES
    • Accountable for right subjects and right data to meet or contractual requirements. Collaborate with project leader and LCA to establish an integrated set of plans with CL to be ultimately accountable for results of the clinical team. Will represent clinical delivery with customer.
    • Produce and distribute status, tracking and financial reports for the core project team, other functional groups and senior management.
    • Responsible for tracking financial deliverables, reporting and invoicing on projects
    • Ensures 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.
    • Deliver the project / program according to the quality management plan. Guide CRAs and advise on critical specific study issues
    • Manage 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.
    • Approves final sites lists.
    • Active member of the core project team working with the Project Leader to ensure overall project delivery.
    • Develop the risk management plan from a clinical perspective and proactively coordinate clinical issue escalation and resolution with the Project Leader.
    • Collaborates with other functional groups such as Global Delivery Network (GDN), Labs, Data Management, Pharmacovigilance, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles.
    • Provide ongoing training and support to the clinical team. Conduct team meetings and ensure regular communication.
    • Contribute to best practices in driving high performance and efficiency of the clinical team through CRA project objectives and conduct of monitoring visits. Provide performance feedback to management on clinical team members.
    • Provide thought leadership in utilizing appropriate clinical tools, processes and GDN for the study team to support the execution of clinical deliverable and study timelines.
    • Collaborate with CRA Resource Manager on CRA development.
    • Provide project leadership to CRAs.
    • Participate in RFP development and sales/proposal presentations; provides input on scope and budget development.
    • Mentor and coach new peers as they assimilate into this role.
    All responsibilities are essential job functions unless noted as nonessential (N).

  • Master Scientist, Clinical Studies
    January 2013 --- January 2014
    Clinical Study Management: Managed clinical studies under jurisdiction and transition of 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. Provided input for study brochures, clinical study protocol, and all other regulatory documents for document submissions. Provided significant input on bi-annual review of rudimentary SOPs to achieve higher level of consistency and adherence to established laws, regulations and global standards already observed by the biotechnology, pharmaceutical, medical device and CRO industries. Protected both: a) study subjects’ safety, wellness and privacy, b) public health. Developed and accounted for expenditure of study project/study budgets. Led Kick-off meeting with study vendors.

  • Senior Clinical Affairs Consultant
    January 2007 --- January 2012
    Consulting company (LLC) established to provide project and clinical study management, clinical study monitoring - domestic/international – services for the biotechnology, pharmaceutical, medical device, medical equipment, and CRO industries. Ensure Code Federal Regulations, Title 21, Parts 11, 50, 54, 56, 312, 314, ICH, GCP, PMA, 510K, IDE (812), ANSI/AAMI/ISO 141155:2011, HIPAA, State(s) and local regulations are followed to ensure quality and integrity of clinical study data and study results. Lead clinical team representatives - Project Management, Regulatory Affairs, Quality Assurance, Statistics Department, Data Management, Study Management, Clinical Operations, Investigational Review Boards, and Vendor Representatives - from study kick-off meeting to study closeout.

  • Consultant – Sr. Clinical Research Manager
    January 2010 --- January 2011
    PROFESSIONAL EXPERIENCE Consultant – Sr. Clinical Research Manager Provided clinical research consulting services in the planning, initiation, execution, and close-out of fast paced OTC global, but mono-center clinical (PK and Dental) studies at different stages (planning, initiation, execution, and close-out) - Phase 1 and Phase 2.

  • Associate Director, Clinical Protocol Manager
    January 2008 --- January 2009
    Oversaw the conduct of Inflammation, Rheumatoid Arthritis (RA), global clinical studies, Phase 1 and 2, to ensure compliance with Federal, country, local regulations, company SOPs and guidelines within approved timelines and resources. Contributed in the development of 3 study drugs for RA and their respective lifecycle: Phase 1 to Phase 2 under high degree of complexity. Developed overall project strategies; led cross-functional operational planning, conducted and completed multiple Rheumatoid Arthritis (RA) global clinical studies within programs alignment and resources while maintaining high degree of Quality Assurance. Oversaw and participated in study team operations and discussions covering all needs in the planning, execution, and closeout of clinical studies.

  • Consultant
    January 2007 --- January 2007
    Planned, initiated, and closeout a seasonal Acute Upper Respiratory Infection clinical study, Phase 4, clinical study conducted under very challenging timeline. Led the senior CRO project team selected to conduct the study.

  • Clinical Project Manager / Contractor
    January 2004 --- January 2006
    Provided quality consulting services to oversee contracted CRO and vendors' activities for the Respiratory Department, Medical Affairs, leading to successful planning, conduct and completion of outsourced Respiratory clinical studies and IITs. Managed 10 plus Respiratory Anti-infective Investigator Initiated Trials (IITs) for Key Opinion Leaders (KOLs) from synopsis to report. Liaised with KOLs, PIs, and research staff to ensure proper study conduct, collection of study data, and issuing of study report.

  • Senior Clinical Research Associate (CRA)
    January 2002 --- January 2004
    Supervised, co-monitored, and supported the administration and progress of Congestive Heart Failure (CHF) REVIVE I and II global clinical study, Phase 3, in Australia, Canada and the US. Wrote, implemented, coordinated, managed, and executed the Motivational Site Visit Plan that led to Subject enrolment increase for this clinical study.

Knowledge

LinkedIn Assessment :
Clinical researchFDAClinical trialsMedical DevicesClinical Study DesignBiotechnologyGCPProtocolDrug DiscoveryQuality AssuranceCell CultureMedical writingInfectious diseasesVaccinesCROPre-clinical researchRegulatory submissionsINDInformed ConsentCancerICH-GCPmanagementPharmaceutical DevelopmentProduct developmentClinical Study MonitoringQuality ControlSafe Use of RadioisotopesClinical Study ManagementClinical Project ManagementTesting of Radiolabeled Antibodies (Pre-Clinical)Production of Rabies VaccinesCancer Cells Transplant (Pre-Clinical)Global Regulatory ComplianceTrial ManagementSOPClinical operations

Education

  • in Certificate, Project Management from Rutgers University-New Brunswick in 0
  • in Ingenieria Quimica from Universidad Autónoma de Santo Domingo in 0
  • in Colegio Universitario (CU) from Universidad Autónoma de Santo Domingo in 0
  • Certificate in Project Management from Eastern Connecticut State University in 0
  • Certificate in Foundations of Clinical Research and Study Design from Mercer County Community College in 0
  • Diploma in Network Engineer: Microsoft Certified Professional (MCP) - MCP, MCSE, MCP+I, CNA, CompTIA A+ from PCAge in 0
  • DVM in Doctor en Medicina Veterinaria from Universidad Autónoma de Santo Domingo in 0
  • Master of Science (MS) in Master of Science from University of Missouri-Columbia in 0

Training and Certification

  • Certified Clinical Research Associate (CCRA®) Certification

Languages

BrightOwl Assessment:
Self Assessment:
Spanish
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Associate Director Clinical Operations Associate Director - Head of Preclinical Immunology - Bacterial Vaccines Clinical Development Consultant Clinical Research Associate (CRA) Clinical Trial Manager (CTM) Global PM Global Clinical Project Manager (GCPM, GTM) Veterinarian
  • Work From Home:
    Yes, 5 Days
  • Work Regime:
    Permanent position
    BrightOwl freelancer
  • International:
    Yes

Area / Region

Piscataway Township, NJ, United States

Others

Driving License
  • No