Clinical Study Specialist.

Madhuri Gadekar

**** *********** **., *** ****, California - 95131

Contact

Phone: 858-***-****

Email: aczziy@r.postjobfree.com

Certifications

Design and Interpretation of Clinical Trials (John Hopkins University) August 2016 Data Management for Clinical Research (Vanderbilt University) August 2016 Good Clinical Practice Guideline Certification (ICHGCP guidelines) September 2016 Base SAS Certification (SAS Institute) September 2015 Technical Skills

Languages: Base SAS, Clinical SAS, SQL Basics Office Tools: Microsoft Word/Excel/Power Point

Professional Experience

Clinical Study Application Specialist (iNDx Technology, INC.) September 2015 – Present

• Part of a team that develops clinical trial management solution for PICI. Driving requirements of the product by acting as a domain expert in the field of Clinical Research. Proactively identify challenges faced by clinops teams and provide the solution. Responsible for creating specification and requirement document and communicating with the project teams about scope, workflow and deadlines.

• Handling the responsibility of providing insights about the product to Investigators and product users. Medical Intern (SKN Medical College and General Hospital) March 2013 – March 2014

• Outlined various modes of management including drug therapeutics especially dosage, side effects, toxicity, indications, and contraindications.

• Diagnosed and prescribed drugs based on patient’s medical history. Provided first level of management of acute emergencies, promptly and efficiently and decided the timing and level of referral, if required. Worked in all departments of the hospital on the rotational basis. Academic Projects

Study of Menstrual Hygiene in Indian Rural Population June 2013 – August 2013

• Conducted a community based cross sectional study focusing on status of hygiene and practices regarding menstruation among adolescent girls in urban slums. Study of Antiepileptic Drugs on Various Hematological Parameters January 2010 – June 2011

• Conducted comparative study to determine long-term adverse effects of antiepileptic mono-therapy, conventional combined therapy and new combination therapy. Professional Summary

I am a certified Clinical Data Manager and Base SAS Programmer diligently overseeing oncology clinical trials. Have insights about design, development and execution of operationally feasible clinical studies in accordance to medical program strategy with thorough understanding of both medical and analytical fields. I have working experience in developing trial management software solution. I have knowledge of current USFDA regulations, ICH and GCP guidelines.

Specialties: Medical insights, medical terminologies, SOP development. Education

Master of Science in Pharmacology and Toxicology

Long Island University, NY, US

December 2014 – December 2016

GPA: 3.8/4.0

Relevant coursework: Biostatistics, Current Technologies in Pharmacology, Human Carcinogenesis, Pharmacogenomics, Pharmaceutical Laws and Enforcement, Cancer Immunotherapy Bachelor of Medicine and Bachelor of Surgery

Maharashtra University of Health Science, Pune, India June 2008 - March 2013

GPA: 3.4/4.0

Relevant coursework: Anatomy, Physiology, Biochemistry, Clinical Pharmacology, Pathology, Microbiology, Community Medicine, Pediatrics, Obstetrics and Gynecology, Medicine, Surgery. Awards

Excellent Graduate Student Award- Long Island University, Brooklyn. December 2016

• Won award for exceptional academic performance throughout master’s degree along with Rho-Chi society award for exceptional academic performance for 2 consecutive semesters. Student Fellow at Molecular Med TRI-CON 2017 February 2017

• Selected as a top 20 Fellow students for poster presentation at Molecular Med Conference.

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