Dr Dhiraj Patel

[F*-***-Silver Stroke Apartment, Bopal] • [Ahmedabad, Gujarat, India 380058]

+91-989******* adgokd@r.postjobfree.com linkedin.com/in/dr-dhiraj-patel-7b997b111

Professional summary

12 + years of industry experience extensively in Clinical Data Management. Throughout the career worked globally with the most reputed Clinical Research Organization and Pharmaceuticals and was responsible for revamping, establishing, and executing Clinical Data Management activities following regulatory requirements & standards like CDASH across the globe. Heading the Department of Clinical Data Management gain splendid experience in ensuring client satisfaction in terms of quality, time, and cost.

Worked on 115+ studies from various therapeutic areas like Oncology, Patient PK, Psychiatric, Immunology, Vaccine, Gastroenterology, Metabolism, Dermatology, Metal Allergy, Ayurvedic, Nutraceuticals, Personal Health Care, etc.

Skills

End to End Clinical Data Management

CDASH-SDTM/ CDISC Implementer

CDISC Reviewer

Subject Matter expert for EDC development

GCDMP follower and expert

Hands-on experience on various EDC Platform-Oracle Clinical, ClinTrial, BizNET CTM, SAS PheediT, Trianz Acceliant, Octalsoft, Clindox, Amedon

Experience

December 2018–current

Director • Head-Clinical Data Management • Velocious Clinical Research

Accountable for process implementation, Resource identification and management, Mentoring, Project management, client approach, revenue generation, and business development.

Client’s contact and collaboration

Responsible to conduct the study activities in accordance with in-house SOPs, Regulatory guidelines, and standards like CDISC

Review CDISC package (from 2019)

October 2016–December 2018

Manager-Senior Manager • Head-Clinical Data Management • Karmic Life science, LLP (Cliantha Research Group)

Accountable for all CDM activities and deliverables

Project Management, driven by weekly meeting with team, project tracker, Data metrics

Mentoring and Liaison with multidisciplinary team/ departments

Resource Management includes timely shifting of ideal resource to meet the project timeline, recruiting new people, maintaining low attrition

Process enhancement and implementation by using standards like CDASH-SDTM/ CDISC

Assist the CDISC team for implementation and review of CDISC output (2017 onwards)

Business development

Filling process gap by developing SOPs, working manuals Dr Dhiraj Patel

[F2-103-Silver Stroke Apartment, Bopal] • [Ahmedabad, Gujarat, India 380058]

+91-989******* adgokd@r.postjobfree.com linkedin.com/in/dr-dhiraj-patel-7b997b111

Face audit conducted by sponsor auditor and regulatory inspection conducted on CDM

Implemented CDASH compliant data collection process for BABE studies

Accountable to enhance in-house web-based EDC software (Code Angelo)

Perform medical coding

Perform PMS and appraisal using KRA and KPI tools May 2010–September 2016

Officer-Assistance Manager • Team Lead • Lambda Therapeutic Research Limited

SPOC and responsible for all CDM related activities

Oversees the entire project work starting from the set-up, conduct, and close-out phase of the study. In- depth involvement in the initial two years as an Officer

Assisted/performed CDM documentation, DB set-up, Query management, SAE / Lab data reconciliation, Medical imaging data review and inputs, Medical coding, database audit, system audit, database lock

Leading BABE eCRF design team and supervised for more than 1000 studies

Subject Matter Expert for CDMS (web-based BizNET CTM system) implementation and enhancement

Implement CDASH standards (mid-2016 onwards)

Support the CDISC team for CDISC implementation (2016) November 2008–May 2010

Research Associate • Jr. Data Manager • Cadila Pharmaceuticals Limited

Paper CRF development and Database designing, CRF tracking, data entry, data validation, SAE tracking, and query, etc.

Other Experience

General Practitioner from March 2003 - November 2008

Trained under MD medicine and pediatric doctors and handled emergency during the internship

Full time trained under MS surgeon and managed minor accidental injuries

Full time trained under MD physician as a Medical officer

Education

Certified Oracle Database 10g –SQL - ITS data solutions Pvt Ltd, Ahmedabad’ Gujarat, India, JUL 2012

PGDCDM, ICRI-Ahmedabad- JUN 2008 - JUN 2009

BHMS- Sardar Patel University, Anand-Vallabh Vidyanagar SEP 1996 - APR 2001

Conference and Workshop

Attended WHODrug™ User Group Meeting – Feb 2016 at Bangaluru.

Attended “Workshop on coding” organized during the SCDM Asia conference 2013, Mumbai Dr Dhiraj Patel

[F2-103-Silver Stroke Apartment, Bopal] • [Ahmedabad, Gujarat, India 380058]

+91-989******* adgokd@r.postjobfree.com linkedin.com/in/dr-dhiraj-patel-7b997b111

Attended “The Changing Landscape of CDM: Transformational Trends and Technological Innovations” by SCDM Asia conference 2013, Mumbai “3rd Annual Clinical Development and safety Forum” in Oct 2009 at Mumbai

FDA Smart Inc. program in Sept 2008: “Understanding FDA and FDA Approval Process”

Presenting DM roles through Investigator Meeting

Leadership

Developed an entire set of global CDM SOPs and released in a single day- Lambda

Proactively implemented the CDASH-SDTM compliant Data Collection Standards-Lambda

Assisted to develop a web-based system and deployed in one year -Lambda

Deployed in-house CDMS at Lambda-Canada through virtual Supports-Lambda

Many times achieved a 100% data quality index

Supervised/executed more than 115 projects

Streamlined the existing process by revising an entire set of SOPs at Karmic life sciences.

Supervised EDC enhancement at Karmic (KTrial to CodeAngelo)

Cleared about 3-years project backlog-Karmic

Supervising 25-30 employees at any points of time during Lambda and Karmic tenure

Data Management Projects

Reference

On request

Declaration

I hereby declare that provided information is correct to the best of my knowledge. Dr Dhiraj Patel,

Date: 29 September 2020

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