Steve Amoratis Email & Phone Number

Durham, North Carolina, Us

Global Clinical Operations Director -for Oversight Monitoring, Global Clinical Monitoring , Study Startup and Precision Medicine.

Leopardstown, Dublin, Ie

Present Contract:• Perform all responsibilities for Janssen Early Development and Clinical Pharmacology team; site feasibility/pre-site assessment, participate in Investigator meetings, site start-up, site monitoring, site management through close-out. Phase 0, 1, 2a and 2b.-only.• Contributes to site level recruitment strategy, contingency planning and implementation with other functional groups to achieve research targets. • Maintains study supplies and ensure clinical drug supplies are accurately used, handled, and documented.• Ensure accuracy, validity, and completeness of data collected at study sites and trains staff, as necessary. • Ensure all AEs/SAEs/PQCs are reported correctly/timely in accordance with cGCP, J&J SOPs and study protocol.• Ensure all Essential documents are accurate and maintained within sCTMS, mCTMS, eTMF, vTMF and Sharepoints. • Work with functional team members to resolve CAPA,QA site issues, and achieve audit-ready status.• Fulfills all sponsor reporting requirements and timelines according to SOP and monitoring protocol instructions.1YearContract monitor for CoreValve-Medtronics Structural Heart Division in the northeast. Responsible for Fletcher Allen Medical Center/University of Vermont, Mt. Sinai, Lennox Hill and MedStar-Washington Hospital Center, Washington D.C.

• Performing and coordinating external clinical studies to include site selection, protocol development, and close out. • Preparing reports, and publications required for product launch.• Maintaining contact with study investigators to make sure studies are actively enrolling. • Performing internal performance audits against investigator sites and staff.• Reviewing cases with investigators and staff to determine discrepancies and close queries.• Early Phase Oncology trials in RAS/MEK inhibition for Melanoma and Non-small Cell Tumor.

Launch strategist for global commercial markets across all product lines.Directly responsible in engaging new contracts within C-suite leaders for major medical centers.Lead product manager/marketing analyst for Nutrascreen web-user integration. Director for clinical research applications in pharmaceutical, university, federal and private studies.Clinical manager for phase II -IV trials involving Nutrascreen and Vioscreen. Primary contact for Pharmaceutical and CRO protocol design-study inclusion.Clinical research manager for phase IV post marketing adult obesity studies.Current research: Nestle Pediatric Obesity Study- Assisted IRB design for study sub-population.Experience with site enrollment and initiation of study sites according to GCP-ICH standards.

• Lead research and QA -Auditing team that is introducing new medical products from emergent markets into the USA office and hospitals. • Training manager for all Regenerative products; Cerasorb M, AlloSorb, Collagen Membranes and Bacterin Allograft.• Regulatory specialist for filing of CE products to FDA for medical inclusion in USA market.

• Lead product development team and trial team for new titanium micro-thread design and Trabecular metal design.• Team lead -prospective pilot clinical study of Trabecular Metal Dental Implants, and multi-national Trabecular Metal Implant study 137 patients across 8 study sites in Northeast.

Charlotte, North Carolina, Us

Clinical Research Associate• Study Lead Monitor for new Ankylos CX endosseous implantable device system at NYU Medical Center-90 subjects with 3 month, 6 month and 1 year post index follow up. • Study development team for PEPGEN-15 novel human peptide and bovine grafting materials. Staff Development• Hired, trained, managed and mentored highly motivated individuals and gave the tools and training to succeed.• Directed sales staff in forecasting and setting attainable goals and helped each account executive execute an individual strategy.Customer Relations• Coached and developed four nationally recognized Key Opinion Leaders in the field of Implant Surgery for national speaking roles.

• In-house CRA monitor for 4 sites in Northeast region conducting SIV through COV.• Co-authored EKG monitoring protocol for IRB-submissions to Columbia University on “The Utility of Home Telemetry monitoring in the assessment of Atrial Arrhythmia pre and post Surgical Maze and Catheter ablation.”• Directed and executed strategy into Pharmaceutical research and CRO’s accounts for device use in studies. • Primary research liaison to central labs EKG supporting drug discovery for Merck, Novartis, Sanofi, BMS, Pfizer and J&J. • Established protocol for patient monitoring inclusion/exclusion in Phase1-4 studies and all post marketing applications. • Responsible for feasibility / enrolling New York Presbyterian Health System, later became Cardionet’s largest commercial account.

Marketed Ambien, Avapro, Plavix, and Uroxatral to hospitals and physicians; * Trip winner and award of excellence for being a top sales producer for Ambien in 2003.* Developed a relationship with interventional Cardiology at Columbia Presbyterian, resulted in a 20% increase in the hospital's purchase of Plavix. * Achieved formulary placements for Avapro at Lennox Hill Hospital and Ambien at Gouverneur hospital.* Ranked in the top 10% of Sanofi's sales force nationally; #6 out of 63 specialists in the Northeast. * Exceeded quarterly sales goals by an average of 10%, every quarter for two years.Medical Science Liaison on the CURE Study for Plavix. * Developed NYC based Interventional cardiologist to lecture at local events in NYC.

Lawrence Township, Nj, Us

* Marketed Avapro, Tequin, Serzone, Buspar, Glucophage, Dovenex, and Lachydrin to physicians in lower NYC. * Award winner for 1st place in anti-depressant Serzone prescription volume, revenue, and market share regionally - 3rd place nationally. * Achieved formulary placement of quinolone anti-infective Tequin (I.V.) at St. Vincent Hospital. * Increased injectable antibiotic sales by 5% within launch year by getting preferred formulary status.

* Vioxx post marketing phase IV studies and expanded indications research. * Conducted office based sales of Vioxx, Maxalt, Zocor, Cozaar, and Vasotec to physicians.* Increased market share of Maxalt by 4% within three months.* Increased territory ranking from 54/400 to 41/400 based new prescription market share.

-Research assistant to lead investigator on Vioxx.-Maintained logs and study protocol for FDA submission.-Complied with all government regulations and cGXP.

* Managed a medical equipment service team that focused on wound care. * Managed 15 direct reports that serviced NY and NJ acute and long-term care. * Developed, trained, and certified new service technicians.* Increased service contracts within NJ service territory.

Bs, Biololgy/Chemistry

Certificate, Certified Clinical Research Professional

- A.S, Electronic Technology

Certificate, Artificial Intelligence - Biotech/Pharma