Clinical Data Management Associate

Fabian Arias

Santa Barbara, CA ***** 805-***-****

www.linkedin.com/pub/fabian-arias/35/801/135/ adi36t@r.postjobfree.com

Clinical Data Management Associate

Exceptional organizational, communication, and interpersonal skills

Energetic, motivated, team-oriented professional with expertise in qualitative and quantitative research data management in medical device industry. Processes documentation of clinical trials to ensure compliance with FDA regulations. Easily grasps and puts into application new ideas, concepts, methods and technologies. A great listener, who puts good humor and passion to work to meet any challenge. Bilingual, with fluency in English and Spanish.

Professional Experience

MENTOR WORLDWIDE, LLC., Santa Barbara, CA 2007 – 2014

A Johnson & Johnson company

Leader in global aesthetic and reconstructive surgery marketplace. Develops, manufactures and markets science-based products for surgical and nonsurgical medical procedures, with annual sales of approximately $400M worldwide.

Data Management Associate II 2008 – 2014

Verified protection of rights and well-being of human subjects and to ensure accuracy, completeness and verifiability of reported trial data from source documents. Documented trial compliance with currently approved protocol / amendment(s), GCP, and applicable regulatory requirement.

Improved data quality and ensured compliance for multiple medical device studies by reviewing study protocol and assist site coordinators, investigators, and field clinical staff in collecting routine data to meet FDA & HIPAA requirements in a timely manner. Identified, tracked, and resolved routine queries.

Addressed FDA questions and concerns regarding silicone gel filled breast implants by participating on teams submitting study reports.

Helped broaden customer relationships with company by providing clinical support and maintaining communication with study investigators, surgical centers, and hospitals in large territory across US.

Created statistical reports consisting of quantitative study data and worked closely with upper management, ensuring quality preparation for FDA submissions.

Assist with review of Case Report Forms, Edit Checks, Data Management Listings, Query Listings, and Patient Profiles for data cleaning.

Input all incoming US and Canadian silicone memory gel implant device forms in device tracking database, keeping information up-to-date and ensuring accuracy of clinical records.

Fabian Arias Page Two

Santa Barbara, CA 93110 805-***-****

www.linkedin.com/pub/fabian-arias/35/801/135/ adi36t@r.postjobfree.com

Technical Skills

Proficient in MS Office, Medidata, Salesforce, ClinAccess and Powerserver

Typing (60+ words per minute); 10-key punch

Education

California State University Channel Islands College

BA, Psychology, California State University Channel Islands College, Camarillo, CA, anticipated graduation 2023

Santa Barbara City College

AA, Liberal Arts and Sciences, Santa Barbara City College, Santa Barbara, CA, graduated Spring of 2017

Santa Barbara City College

Professional Development Studies, Health Professions and Related Programs

2012-2013

Business writing, Time management, Strategic communication, Stress management, Business etiquette, Personality styles @ Work, Problem solving & Decision making.

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