CURRICULUM VITAE

SUHAIL KHANEmail : suhailkhan1989@gmailContact : 8878719495Address : G-1 Subedaar colony 2nd Batalion S. A. F kampoo lashkar Gwalior Madhya Pradesh-474001

OBJECTIVES:To perform well in a challenging environment that offers scope for personal and professional growth and provides me ambit to apply my knowledge and skills for the organization.

WORK EXPERIENCE:Record Regulatory Specialist - 1 | Integrated Neuroscience Consortium Research CDS services pvt.Limited| (May2014-Aug2015)| www.incresearch.com|Gurgaon (Haryana)

Company INC Research CDS services pvt. Limited

Project Title Clinical Record Management for multiple projects

Designation e TMF Record Regulatory Specialist 1

Roles And Responsibilities Adheres to project-specific data tracking guidelines and relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs).

Receives and inventories applicable project documents, e.g., Trial Master File Documentation, Investigator File Documentation, Case Report Forms (CRFs), Data Clarification Forms (DCFs), and/or Data Management Files.

Processes, Quality checks, indexes, publish and maintain files for CRFs, DCFs and data management documents in accordance with SOPs/WIs.

Maintains the security and compliance of all documents related to ongoing projects and archived documents in accordance with relevant SOPs/WIs.

Responds timely to requests for site documents, pulling and re-filing site documents; ensures applicable paperwork is completed upon release from and returned to the Document Control Room.

Participates in preparation/reconciliation of site documentation related to archival/shipping to sponsors.

Participates in project specific training as required.

Respond/process team requests in TMF Management database for any updates,corrections,deletions and overall management of TMF

globally

Management of projects to ensure completion of assignments within established timelines.

Worked in the management of the documentation for studies being carried out at sites globally.

Completely analyzing the documents, classifying them into pre-determined sub-classes and uploading them into the Client system for audit purpose from the client end.

Maintaining track record of every document being shared by the sponsor and every document imported into software designed by the client for easy archival of electronic formats of the document.

Adherence to all rules and regulations governing the process- ICH -GCP Guidelines and 21 CFR Part 11 (Electronic Records and Electronic signatures).

Receive the Clinical data from client and review them for accuracy, Generate queries to clarify and improve the quality of the data and ensure compliance.

Compile and format Clinical and Regulatory documents for submission to regulatory agencies in standardized format using electronic tools as specified by USFDA, MHRA, ICH regulatory agencies.

Uploading of all received, Electronic Clinical Records while maintaining 100% accuracy in the repository.

Provide training on good records management practices, Policies and systems as per client SOP.

PROFILE SUMMARY

Have 15 Months of Experience in Clinical Research Organisation

(12May2014-13Aug2015)

KEY SKILLS

Professional skills:

Good understanding of ICH-GCP, 21 CFR guidelines.

Knowledge about Protocol, Investigational Brochure, Data Clarification Form, Monitoring Visit Records, Essential documents.

Knowledge about Regulatory and IRB-IEC documents.

Excellent attention to detail and accuracy.

Can take responsibility for tasks and react to changing priorities.

Good interpersonal skill and able to work in a team or own if required.

Technical skills: Diploma in computer application and Proficient in MS Office suite, Internet, MS-excel, power

point, internet and have the relevant knowledge required to succeed in any basic role.

Worked on different softwares and the software I worked in INC was Trail �interactive which is a very advance form of software.

Personal skills:

Fast Learning & Problem solving attitude Highly committed individual. Ability to take the initinitiatives. Self-motivated and an excellent team player Adaptable, able to adapt to new surroundings. Ambitious, have a strong desire to do something good. Efficient and capable to get results. Smart working, honest, organized, innovative, people-oriented, Reliable. Ability to work well under pressure.

Weakness :

I am straight forward in giving my opinion. I trust people blindly.

ACADEMIC CREDENTIALS:

Degree Board/Institute Grade Year Of Passing

B.pharmacy School of studies in pharmaceutical Research. Jiwaji University, Gwalio(M.P)

A 2013

D. Pharmacy Jamia Humdard University, Delhi

A 2009

Intermediate Kiddy's corner School Kiddy's corner School A 2006

Central Board of Central Board of Secondary EducationSecondary Education

MatriculationMatriculation Kiddy's Corner SchoolKiddy's Corner SchoolCentral Board of Central Board of Secondary EducationSecondary Education

A 2004

ACHIEVEMENTS: Professional Achievements:

Working experience of eTMF plans of different projects including the complicated Japanese studies.

Top quality and quantity processing of documents.

Promoted to QC 2 processing in short term after joining.

Provided Training sessions to new joiners on general TMF work.

Made changes in the TMF plans time to time for the convenience of the studies as per my understanding.

Got rewards like I-fish and many verbal appreciations for my work, also got other appreciation for good communication skill, good email writing.

Over the complete period of time in INC research I had believed in my individual strength and as a team worker.

Other Achievements:

Participated in National level Seminar on “Impact of Pharmaceutical Education on Employment” on Dec 2010.

Registered pharmacist in Delhi Pharmacy council.

5 years teaching experience in coaching institute.

Participated in state level and distric level Table Tennis Tournaments.

Co-Curriculum projects and internship: Research work done in Ayur pharma, Baraghat, Gwalior and submitted as a part of project

in Bechalor Degree on "Establishment of an Ayurvedic Medicine Manufacturing Unit" under the guidness of Dr.Fakhruddin Ahmed Qureshi.(2012-2013)

Second Research done on project "performance Enhancing Drugs in sports" under the same as above Degree and Guidence.(2012-2013)

3 months internship training in Dispensing and Storing from St.Stephen Hospital, Delhi.(2009)

45 days internship experience in Production Unit from NAPROD LIFE SCIENCE, Mumbai.(2011-2012)

2 month working experience in sales and marketing from Micro Labs pvt. Ltd

PERSONAL INTERESTS: Determination activities like running, cycling, tracking, climbing, and fond of other sports

activities. Played at state level in table tennis and cricket.

Travelling, puzzles solving, computing, cooking, listening old, soft and Sufi Travelling, puzzles solving, computing, cooking, listening old, soft and Sufi music,music,

Discussion on social and current topics with friends and family. Discussion on social and current topics with friends and family.

PERSONAL DETAILSName : Suhail khanD.O.B : 28/06/1989Languages Known : English, HindiNationality : IndianReligious : Muslim

DECLARATION:I hereby declare that the statements made above are true, complete and correct to best of my knowledge and belief.Place: Delhi suhail khan