Manager Management

CHIRAG PADHIAR

***, ******* ******, ***#*, Boston, MA 02120 857-***-**** *******.*@*****.***.*** https://www.linkedin.com/in/chiragpadhiar/

Summary

A passionate, positive, proficient and dedicated individual with a desire to achieve, excel and evolve

Excellent years of work experience in clinical trials & product management

Detailed understanding of Data Management and Regulatory Documentation processes

Thorough knowledge of the execution of Paper & EDC trials

Hands-on work experience on Electronic Data Capture/Management systems like Medrio, Medidata Rave, Inform

Strong and comprehensive Clinical Data Management skills spanning from study start-up, study conduct and close out activities, with hands-on experience in following activities

Creation and review of Data Management Plan

Create Edit Checks Specification and UAT programmed edit checks

Perform data cleaning activities, such as issuing & closing queries

Generate progress report for the study team

Perform database locking

Experience in selection & designing of Case Report Form pages and database building activities

Sound understanding of medical coding using MedDRA and WHO Drug dictionaries

Extremely data-oriented approach with proficiency in tracking, reconciling, formatting and reporting data as required

Experience in the compilation, updating and maintaining of Trial Master Files (TMF)

Involved in developing/reviewing departmental SOPs and Guidelines

Working knowledge and practical understanding of all applicable FDA/EMA/International/ICH GCP regulations and guidelines relating to Drugs, Biologics and Medical Devices

Extensively strategic, detail oriented, creative and quality oriented approach to work

Excellent interpersonal, organizational and written/verbal communication skills Education

Northeastern University Boston, MA

Master of Science in Project Management, concentration Clinical Trial Design, Expected 07/2018 Course work: Human Experimentation, Regulatory Affairs Strategic Planning Management, Clinical Trial Design Optimization, Validation & Auditing of Clinical Trial, Leading Remote Project Teams, Risk Management, Scope Management, Project Management Practices, Project Scheduling & Cost Planning, Principles of Agile Project Management

L.J Institute of Pharmacy Gujarat, India

Bachelors of Pharmacy

Course work: Pharmaceutical Biotechnology, Microbiology, Biochemistry, Organic Chemistry, Formulation Development and Design, Medicinal Chemistry, Pharmaceutical Technology, Biopharmaceutics and Pharmacokinetics, Pharmacology, Phytopharmaceuticals Skills & Achievements

Computer skills:

Medidata Rave 5.6.4 – CDMS tool

Medrio EDC (version 34) – EDC software

Inform 4.6 – EDC CDMS

MS Office – Word, Excel, PowerPoint, Visio, Access, Project

Jreview 11.0.1 – Analytical tool

ePro – Clinik

Minitab, Adobe, SharePoint, Salesforce CRM, SQL, Jira Regulatory skills:

IRB requirements, developing clinical protocols, ethical issues involved in clinical trials and CTA filings

CRF, SAE reporting, regulations pertaining to international clinical trials and IRB review Noteworthy Achievements

Provisional PATENT registered for the work amid graduation in field of Pharmacy

Six Sigma certification

Experience Highlights

Glenmark Pharmaceuticals, India

Clinical Data Manager (11/2015 – 12/2016)

Supported and managed multiple activities of clinical trials from protocol development, UAT to database cleaning and database lock activities in MEDIDATA RAVE, delivering benchmark data quality for analysis and regulatory submission

Ensured regulatory compliance with affiliated vendors and different investigational sites with predefined company SOPs, FDA and ICH guidelines

Contributed and worked with principal investigator(PI) and sub PI, Clinical Program manager, CRA, Statistical Programmer and Biostatistician, Regulatory department as well as project management staff to deliver project objective within provided timeline

Executed tasks like User acceptance testing (UAT), reports generation, reports review, risk management, query management, Serious Adverse Events reconciliation, Lab reconciliation, medical coding using MedDRA, WHO DD

Interacted extensively with the Clinical Data Coordinator, the Study Specific Programmer in facilitating the timely closure of errors, missing information, discrepancies with appropriate audit trail in clinical research database

Reviewed and identified data queries(DQs) for eCRF (depending upon audits, internal team review and report) to ensure quality of the data

Handled communication and interactions between CRO’s and vendors (local or central labs.) for collection, transfer of the study specific data collection Systopic Labs., India

Product Manager (12/2013 - 11/2015)

Contributed as point of first reference for all product related enquiries and work collaboratively with colleagues in Clinical Research and Regulatory to address any issues that may arise

Reviewed product data to ensure that the field force is kept up to date on new developments regarding the companies or competitor’s products

Developed annual marketing plan for controlling advertising, promotion and sales aids in accordance with the annual marketing plan and liaised with the advertising agency regarding the product campaign including journal advertising, direct mail and conferences

Managed the sales team with the necessary technical expertise to enable them to sell the product. This involves printed and electronic promotional material, product training, and relevant clinical papers

Responsible for preparing product forecasts, and constantly monitoring inventory levels held at central and interstate warehouses including communication with production (locally and globally) to ensure supply timelines

Introduced new products to market by analyzing proposed product requirements and product development programs; preparing return-on-investment analyses; establishing time schedules with engineering and manufacturing

Reviewed product data to ensure that the field force is kept up to date on new developments regarding the companies or competitor’s products as well assessed market competition by comparing the company's product to competitors' products ACADEMIC PROJECTS

Drafted an Informed Consent, Protocol, SOP, Investigator Brochure, pre-IND meeting request and an IND submission in electronic Common Technical Document format as a part of academic project to enhance good documentation practices.

Poster presentation on “Product Development Cycle” at Pharma Venture 2013, Gujarat, India

Attended a seminar on “Innovation in Pharmaceutical Industry: From Drug Development to Distribution”, Gujarat, India

Active participation in Scientific Session of 61st Indian Pharmaceutical Congress, Gujarat, India SEMINARS ATTENDED

Attended in state level seminar on " Polymorphism and Genotype – Phenotype correlation of drug response in Indian Population", Gujarat, India

Attended state level workshop on "Hands on training workshop on Preclinical Research"

Presented poster on "Reversal of Type II Diabetes" at National Level Symposium

Attended state level seminar on " Novel Targets in oncology", Hyderabad, India

Attended workshop on "Emerging Trends In Pharmaceutical Sciences"

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