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Clinical Research Management

Location:
Redmond, WA, 98052
Posted:
November 21, 2016

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Resume:

* ** *

Ashwin B. Nambisan, BDS, MPH.

***** ******* ***, *** # * 228,

Redmond, WA 98052

Phone: 760-***-****

Email: acxkyy@r.postjobfree.com

> A clinical research professional with experience managing multiple clinical trials.

> Involved in the design, protocol development, and management of clinical trials involving dental implants, prosthetic and regenerative products.

> Experienced Reviewer of clinical proposals in the clinical trials industry.

> A Periodontist trained to perform all periodontal procedures including dental implants. EDUCATION

PG Certificate in Periodontics,

Rutgers University, School of Dental Medicine, Newark, New Jersey (2015) Master's degree in Public Health (MPH) in Epidemiology, Loma Linda University, California, USA (2005).

Bachelor's degree in Dental Surgery (BDS), Bangalore University, India (1998). EXPERIENCE & TRAINING

Periodontics Resident, Rutgers University, School of Dental Medicine, Newark, New Jersey (2013 -2015)

- Provided Periodontal treatment to patients at the University clinic, Clinical literature review, Conference presentations.

Clinical Research Associate Manager, Zimmer Holdings Inc., Zimmer Dental, Carlsbad, CA (Jan. 2011 - 2013)

- Served as project leader for several types of studies (Sponsored, External or Case series) at various stages including Protocol development, CRF development and Budget negotiation.

- Studies managed cover market areas of Regenerative, Implant and Restorative dentistry.

- Reviewed research proposals as a member of Zimmer External Research Review Board.

- Protocol development, submissions to Ethics committees, data management, analysis and contributor to publications.

Clinical Research Associate, Zimmer Dental, Carlsbad, CA (Oct. 2008 - Jan. 2011)

- Led efforts in reviewing CRFs and developing study protocols by working closely with HCP consultants and internal departments such as Marketing, Statistics & Data Management.

- Experienced in developing spreadsheets for effective study management and obtaining internal and external approvals of projects (CIRC, DARC, IRB, etc.).

- Developed templates for monitoring, site initiation, enrollment log and device tracking.

- Conducted site initiation and clinical monitoring visits and developed superior skills in preparing monitoring reports and resolving site specific issues. Programmer Analyst, Synteract, Carlsbad, California (2006).

- Provided statistical programming SAS support for multiple projects for pharmaceutical and medical device clinical trials in a CRO setting.

SAS programmer, Pacific Data Designs, San Francisco, California (2005).

- Provided statistical programming SAS support for multiple projects for pharmaceutical and medical device clinical trials in a CRO setting.

2 of 3

Consultant, Encore Pharmaceuticals, Riverside, California (2004).

- Analysis of safety and efficacy data for a new periodontal disease treatment regimen. Student Consultant, Health Research Consulting Group, LLU, California (2003-2005).

- Handled clinical research submissions to the IRB at Loma Linda University, the Office of Sponsored Research (OSR).

- Responsible for health promotion/research projects including dental surveys & health marketing.

- Provided support in grant submissions for Loma Linda University health projects, including the Adventist Health Study.

- Chad Dental Survey project consultant for Loma Linda University Dental School. Teaching Assistant, Biostatistics Department, Loma Linda University, California (2004).

- Taught a basic biostatistics lab class and showed students how to use SPSS software. Dental House Surgeon, K.G.F. College of Dental Sciences and Hospital, India (1999).

- Provided dental treatment to patients, and promoted dental awareness through dental camps. TRAINING

Zimmer sponsored research training courses completed:

• Training for Zimmer Supervisors.

• Kepner-Tregoe Project Management (Zimmer Dental).

• Project Management in Clinical Research Conducted by Dr. Eric Morfin (Warsaw).

• Strategies for Managing Difficult Clinical Research Sites (Barnett).

• Clinical Trials Workshop - UCSD Extension.

• Clinical Budget Training (Barnett).

• Certificate in Clinical Registries (Barnett).

• Internal company and departmental trainings including Insight, and ARIBA. Training courses presented by Ashwin for training Zimmer employees:

• Successfully did a scientific presentation on 'Gingival Recession' at the Journal Club.

• Provided HCPs and their study staff of numerous studies with essential, detailed, timely information regarding all aspects of the studies.

• Trained a Contract Research Organization in all the different aspects of a regenerative study, including PowerPoint presentations and a demonstration of the eClinical system.

• Trained other new clinical dental staff on Dental Clinical Procedures and managing the existing and new studies.

• Successfully conducted a presentation on 'How Clinical Studies are Run at Zimmer Dental' as a Snack and Learn Session in 2009.

SKILLS

• Familiar with all aspects of planning clinical studies, including budgets.

• Networking with dental thought leaders in education, industry, & practice.

• Understanding of design, conduct, analysis and ethics of clinical trials.

• Trained in Good Clinical Practices, ICH, and internal SOPs.

• Team player with attention to detail and the ability to manage time and resources efficiently.

• Clinical dental knowledge includes awareness of dental implant systems/products Management skills & Marketing skills including doing clinical and technical presentations. 3 of 3

AWARDS

• Received the Zimmer Impact Award twice in 2011 for being a key player in the FDA submission of multi-center human clinical research related to a new revolutionary dental implant utilizing Trabecular Metal technology.

CONTINUING DENTAL EDUCATION

- Training in Periolase - LANAP protocol (2015)

- All-on-4 course by Dr. Balshi (2015)

- Surgical and Restorative Dentistry Symposium - Rutgers University (2014)

- Zimmer Institute Cadaver course (2014)

- Straumann implant course (2014)

- AAID Maxi-course Implant dentistry (2013)

- Numerous hands-on courses for several implant systems.

- Certificate in Dental Implantology, Smile Care, Mumbai, India (2008), accredited to New York University, School of Dentistry.

- Certificate in Prosthodontics at IDRR, Bangalore, India (2008) CONFERENCE PRESENTATIONS/ ABSTRACTS/ POSTERS

Metropolitan Forum (Tri-school event Periodontics departments of New York University, Rutgers University and Columbia University (2015) Presentation- Management of Peri-implant diseases American Academy of Implant Dentistry (2015)

Table-top Presentation- Clinical Management of Peri-implant diseases Poster Abstract- Clinical Management of Peri-implant Complications: From Theory to Practice Academy of Osseointegration (2012) Poster Abstract- Zimmer Trabecular Metal dental implant studies MEMBERSHIPS

Current: American Academy of Periodontology

Past:

• American Dental Association (ADA) Affiliate member.

• BioPharmaPM (Project consulting in life sciences) member.

• Association of Clinical Research Professionals member

• American Public Health Association (APHA) member.

• American Statistical Association student member.

• Indian Dental Association member.

WORK AUTHORIZATION -

US CITIZEN



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