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Clinical Research & Compliance Manager

Madison, NJ


Work Experience

Clinical Research & Compliance Manager

Medicrea USA Corp.
New York, NY

March 2015 to Present

• Managed clinical trials and operations of spinal orthopedic implants; led both internal and external meetings for multiple clinical studies as per GCP ICH procedures 
• Published and created research strategies for journal articles, case reports and white papers for clinical and biomechanical studies 
• Supported and Interfaced with the Marketing team for evidence based marketing strategies with relevant data as well as existing scientific literature 
• Developed and revised standard operating procedures (SOPs), work instructions, departmental guidelines and auditing programs as per FDA QMS in liaison with external auditors 
• Ensured clinical trial activities were conducted in compliance with FDA Code of Federal Regulations (CFR) with appropriate documentation and reporting 
• Monitored and implemented the Physician Payments Sunshine Act (PPSA) financial transparency reporting requirements 
• Served as primary contact between United States investigators/ surgeons and French clinical team; collaborated across clinical operation teams to organize data, develop ideas, and review metrics 
• Oversaw administration of training-related activities for employees, vendors, and support sales representatives; maintained department training curriculum on current regulatory issues 
• Forecasted budgets for clinical trials, training costs, and consulting fees; balanced and documented forecasted and actual budgets 
• Reviewed and renewed expired contracts and agreements; acted as liaison to negotiate contract terms and facilitate communication among parties 
• Orchestrated collection of data and documents for regulatory FDA pre-market approval (PMA) and medical journal submissions 
• Maintained and updated physician medical licenses and certifications, and departmental database for rules and regulations, processes and audits

Project Engineer

Parsippany, NJ

April 2012 to February 2015

• Modeling and optimization of orthopedic implant and instrument designs utilizing Pro/Engineer design and ANSYS software. 
• Development of prototypes for design verification and validation 
• Utilization and management of design controls within New Product Development (NPDP) 
• Interfacing with clinical advisors to gather input for design and evaluation of new orthopedic implants 
• Development of verification / validation protocols and technical reports. 
• Active participation in and sometimes leading cross-functional design teams to develop new orthopedic products, addressing design issues and maintaining of existing designs 
• Utilization knowledge of the surgical procedure in order to develop innovative solutions to solve and satisfy customer needs. 
• Research plan development and implementation  
• Review and submission of peer-reviewed scientific journals and abstracts

Principal Engineer

Orthopaedic Research Laboratories
Cleveland, OH

May 2011 to April 2012

• Project planning and management of internally driven and commercial client driven physical and computational testing projects 
• Development and realization of test fixtures and execution of testing and reporting 
• Interaction with outside researchers and commercial clients to establish client test requirements 
• Working as a principal scientific liaison with corporate partner such as Austen Bioinnovation Institute in areas of translational research, product development and education 
• Review and submission of peer-reviewed scientific journals and abstracts

Graduate Teaching Assistant

University of Toledo, Toledo OH
Toledo, OH

August 2006 to March 2011

• Interventional Spine, Irvine CA: Cadaveric testing of Percudyn TM using Hemilaminectomy, computation of facet forces using Tekscan and FEA modeling and analysis of Percudyn TM 
• Interventional Spine Irvine CA: Biotribological testing of Percudyn TM based on ASTM/ISO standards 
• Medtronic Sofamor Danek, Memphis, TN: Validation of Slide track analysis using Matlab 
• Disc Motion Technologies, Boca Raton, FL: Biotribological testing of True Disc 
• Innovative Spinal Technologies, Boston, MA: Biotribological testing and FEA analysis of Axient (Dynamic stabilization system) 
• Thekken Spine, Akron, OH: Biotribological testing of E-disc using MTS Bionix Spine Simulator 
• Scient'x , Maitland , FL: Biotribological testing of Scient'x disc using MTS Bionix Spine Simulator 
• Pacific Research Laboratories Inc, Vashon, WA: Mechanical testing of artificial spine using Optotrak System 
• Ellipse Technologies, Inc, Irvine CA: Cadaveric testing of MAGECTM implanted onto a thoracolumbar segment using Optotrak system 
• Magellan Spine, Irvine CA: Disc herniation study using MTS system & intradiscal pressure sensors for lumbar motion segments 
• Spineology Inc, St. Paul, MN: Biotribological testing of "Optimesh" using MTS Bionix Spine Simulator 
• Biomedflex , Denver, NC: Tribological testing of diamond like carbon film coating. 
• Canine Testing, funded by Department of veterinary Sciences, OSU Columbus OH. Cadaveric testing of cervical canine specimens using Optotrak system 
Soft and Hard tissue Biomechanics, Occupational ergonomics, Advanced Biomechanics, Anatomy & Physiology, Tissue 
Engineering, Mathematical Methods for Bioengineers, Research Methods, Orthopedic Biomechanics, Manufacturing 
Entrepreneurship, CAD - Finite Element Methods, Advanced engineering mathematics, Medical Imaging Systems. 


PhD in Bioengineering

The University of Toledo
Toledo, OH

August 2006 to March 2011

BS in Mechanical Engineering

Utkal University
Bhubaneshwar, Orissa

August 2000 to 2004



July 2014 to July 2020

Additional Information

Computer Skills: 
Programming Languages: C, FORTRAN 
Operating Systems: Windows […] MAC OS. 
Computer Applications: ABAQUS, ANSYS 
MiniTAB (statistical analysis) 
MS-Office/ Excel […] 
Lab Instruments: OPTOTRAK(TM) (Kinematic motion analysis instrumentation) 
Strain gauge based pressure transducers 
Mechanical Testing System (MTS) 
Spine Wear Simulator