Resume

Sign in

Clinical Research Data

Location:
Saskatoon, SK, Canada
Posted:
March 19, 2020

Contact this candidate

Resume:

Devang Patel

****-*** ****** **** **** **

Saskatoon, SK S7H 1B2

Cell: 639-***-****

Email: adcc22@r.postjobfree.com

Objectives

Highly talented professional with effective multi-tasking aptitude and ability to work independently interested in the position of Quality Assurance Auditor, offering sound knowledge of quality assurance monitoring and reporting procedures.

Summary of Skills

●Exceptional communication skills

●Excellent verbal and written communication and interpersonal skill

●Conflict handling as well as lead the team

●Creative thinking with great flexibility to adjust to any work environment

●Encouraging attitude

●Familiar with statistical analysis software, SPSS and Prism

●Profound listening skills

●Highly proficient in MS Office Suite (Word, Excel, PowerPoint)

●Strong analytical and problem-solving skills

●Good knowledge of the GCP as well as guideline such as USFDA, CANADA and

EU

Education

R.C.Patel Institute of Pharmaceutical Education and Research – Master of Pharmacy (Clinical Pharmacy)

North Maharashtra University, Maharashtra, India YEAR 2010

S.G.S.P.S Institute of Pharmacy– Bachelor of Pharmacy

Amaravati University, Maharashtra, India YEAR 2008

Employment History

Inventory Associate Oct 2019 - Ongoing

Western Inventory Service, Quebec Ave, Saskatoon SK S7K1V9

●Inventory Data Collection and Verification

●Counting of the materials

●Capturing the different UPC of all products

●Experienced inventory for global retailers, Pharmacy area etc

Associate Scientist (QA auditor) Apr 2016 to Jul 2019

Veeda clinical Research, Ahmedabad, India

●Provides essential support in conduction of Clinical trial at CRO site

●Co-ordinate between sponsor and Clinical Research Department to ensure implementation of study in line with regulatory requirement as well as sponsor expectation in timely manner

●Worked as internal QA auditor from CRO side for BA/BE studies and conduct site audit to ensure regulatory compliance at site in timely manner for CT trails

●Review and resolved regulatory queries received by co-ordinating between different internal stake holders as well as sponsor

●Conduct in-process and retrospective audit to ensure execution of study as per regulatory guideline, protocol and system SOP

●Worked as a team member to host regulatory audit

●Review and resolved sponsor specific concern raised during site qualification audit or study monitoring audit

●Review and conduct system audit for the various departments like Clinic, IT and administration to GCP compliance

●Audit faced: WHO, NPRA, USFDA, ANVISA

●Tracking the final deliverable of the study data to Sponsors as per organization committed timeline

●Assisting the auditors in conducting System Audits.

●Conducting study audits (in-process audit and retrospective audits) of Clinical, Statistical Phases and Preparation & Issue of study audit reports (in process and retrospective audits) for Clinical and Statistical phases.

●Review of Final/Draft study reports and Protocol.

●Review and give comments on the SOPs, Procedures and Policies as per guideline, Controlling and maintain all the final SOPs of the organization to easy retrieve

●Actively involve in the all phases of the software development

●Auditing Data management activity like Data Management Plan, Database design, testing of the database, Counting of QI, pre and Post Database lock activities audit

●Audit of database against the source documents (CRF) to ensure compliance to Protocol, Regulatory requirements, In-house SOPs and SSPs.

●Auditing the clinical study report as well as eCTD of the Final report

●Archiving of the study data as well as all other QA documents

Senior Research Associate (QA auditor) Dec 2013 – Apr 2016

Cliantha Research Limited/Karmic Lifesciences LLP, Ahmedabad, India

●Review of the Protocol and CRF as per regulatory requirement, guideline and as per SOPs

●Audit Data Management Plan, Database design template, Data validation Plan for each study

●Perform testing of the database before finalization procedure

●Perform and conduct system audit as per SOP requirement.

●Perform and audit of study data generate by personal healthcare department, biostatistics and medical writing department.

●Audit the all activities of pre and post database lock

●Review of the Randomization, Statistical analysis Plan and Table and listings

●Audit of the final report as per guideline and study data

●Conduct the system audit of the data management department, IT and Statistical department

●Archiving of the study data as well as all other QA documents

Research Associate (QC auditor) Jan 2011 – Nov 2013

Cliantha Research Limited, Ahmedabad, India

●Responsible for: Doing in-process audit and 100% retrospective audit during clinical study and preparation and review of clinical report.

●To ensure the completeness and correctness of documents pertaining to a study.

●Conduct the system audit for the all the department

●Archiving of the study data as well as all other QC documents

References

●Parth Patel – Manufacturing coordinator at Aurora Cannabis, Saskatoon 647-***-****

●Kaushal – Manufacturing Assistance at Aurora Cannabis, Saskatoon 306-***-****



Contact this candidate