Mr.

Name: MANZOOR Aadil Country: India

Position: Associate Clinical Team Leader

Summary

A Certified Clinical Research Associate (CCRA) from Association of Clinical Research Professionals (ACRP) for the ICH Region. Have been working in the field of Clinical Research for the past 3.5 years and has been working with a Global CRO since Sep 2005 for global/multi-national studies (phase II and III) at various responsibilities including a CRA, Lead CRA, Regional CTL and PM for India specific studies Has significant working experience in Cardiology, Gastroenterology, Infectious Disease, and Endocrinology studies.

Has worked in a multi-centre Phase III study in decompensated chronic Hepatitis B, Hospital-Acquired-Pneumonia, and multi--centre Phase II study in postmenopausal women patients with estrogen receptor positive breast cancer and Phase III Global study for the treatment of Venous Thrombo Embolism Indication. Responsibilities include performing Site Selection, Site Initiation, on site monitoring as per CRO SOPs and sponsor’s SOPs, as applicable. Also involved in Phas III Diabetic Neuropathy and HIV trials as a team lead.

Currently working as a Clinical Team Lead in Phase III Clinical Trial for Diabetic Neuropathy Indication and Infectious diseases study. Primary responsibilities include co-ordination with the sponsor and global CRO team for the conduct of studies at centres in India. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Study set-up and follow-up study activities through ongoing tracking and review of study progress and attainment of clinical deliverables within study timelines. Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Coordinating with third parties contracted by the sponsor in accomplishing the sponsor specified tasks.

Role and Responsibilities are as below:-

 Feasibilities  Initiation visits  Audits

 Attendance to Invest Meetings  Monitoring visits & SDV Inspections

 Delivery of GCP training’s  Closure visits Submission dossier

Submissions to Regulatory body  Query resolution  Collection of regulatory packages

 Submissions to Ethic committees  Drug accountability

 Site Selection visits  Management of SAEs  Re-labelling process

Education / Qualifications

Date Place of Education Qualifications

2008 Association of Clinical Research Professionals Certified Clinical Research Associate (ICH Region)

2003 - 2005 Garden City College, Bangalore Master of Biotechnology.

1999 - 2001 S. P. College, Srinagar Bachelor of Sciences.

Education / Qualifications

Date Place of Education Qualifications

2008 Association of Clinical Research Professionals Certified Clinical Research Associate (ICH Region)

2003 - 2005 Garden City College, Bangalore Master of Biotechnology.

1999 - 2001 S. P. College, Srinagar Bachelor of Sciences.

Employer/From – To

Roles & Responsibilities

As an Associate Clinical Team Leader

01 October 2008 – till date • Responsible for leading the clinical team in a given project(s) and ensuring quality of the project by adherence to good clinical practices, compliance with the protocol and all project procedures, and with the agreed SOPs.

• Responsible for the timely delivery of the clinical project by ensuring that site selection, site initiation, patient recruitment, site monitoring, site close-out, data correction, data transfer and follow-up activities are completed in accordance with the agreed project timelines.

• Responsible for planning and tracking the conduct of the study in compliance with the study budget, the quality standards and timelines.

• Responsible for identification and resolution of project-specific clinical operations issues and problems in consultation with the Project Manager (global/ regional), with an awareness of the project budget, timelines and quality standards.

• To co-ordinate with different service providers within a project (all centralised services, Data management, couriers, another CRO, local affiliate of sponsor)

• To update the Sponsor/ internal customer about the study progress at a pre-defined periodicity.

• To identify, evaluate and suggest resolutions in a timely manner for project risks.

• To conduct periodic study team meetings, teleconferences with the team members and/or Investigators and to ensure that minutes/ action items are appropriately documented and circulated.

• Assist with providing ongoing training and support to the clinical team for the appropriate conduct of the study.

• To make, implement and execute the clinical management plan for the study.

As Senior CRA

01 April 2007 – 31 Mar 2008 The responsibilities of a Clinical Research Associate include:

• Study start up activities including assistance in procuring documents for regulatory package & feasibilities.

• Site Selection, Site Initiation, on site Monitoring and Site closeout visit.

• Maintaining In-house files and tracking of Study related activities.

• Investigational product accountability

• Coordination with sites during SAEs.

• Audit Preparations and data cleaning with DQS resolution.

• Attending trainings and project meetings.

• Site Closeout visits

As CRA

09 Jan 2006 - 31 March 2007

Project Experience in the current Organization

Project description

Description of Responsibilities/Tasks

Including start and end dates

PhaseIndication & Drug class Number Countries Number sites & patients

PhaseIII Diabetic Neuropathy Global 08 Sites/80 Patients Start Date July 2008-Ongoing

Tasks include those described in the ‘Roles & Responsibilities’ of CTL

Phase III HIV Global 02 /20 Patients Start Date July 2008-Ongoing

Tasks include those described in the ‘Roles & Responsibilities’ of CTL

Phase III

Venous Thrombo embolism

Global Study

Approx 25 Sites and 200 Patients

September 2007-Ongoing

Feasibilities- Contacting prospective sites

Collecting Confidential Disclosure Agreements and Site Information Forms from Prospective Sites. Study start up activities including procuring documents for regulatory package

Assisting in the identification of potential investigators and site selection visit

On site monitoring in compliance with the ICH-GCP and relevant SOPs

Liasioning with translating agencies Coordinating for EC approvals and adherence to other regulatory requirements Preparation for Investigators Meetings Preparation for Audits

Site Initiation Assuring investigator’s adherence to protocol and GCP and initiate action to resolve issues during site monitoring visit.

Safety Monitoring Maintaining in-house documents Tracking of documents and activities

Resolving QCs Liasioning with the Sponsor Coordinating for Sponsor Audits. Drug accountability. CRF review

Phase III

Non-ST- elevation myocardial infarctions (UA/NSTEMI) - ACS study

Global Study Approx.40 Sites & 1000 Patients.

Start Date: Sep 2007 - Nov 2007

Assisting in the identification of potential investigators and site selection visit.

Phase III

Hospital-Acquired-Pneumonia

Global Study 12 Sites & 87 patients

December 2006- Feb 2008

On site monitoring in compliance with the ICH-GCP and relevant SOPs

Assuring investigator’s adherence to protocol and GCP and initiate action to resolve issues during site monitoring visit.

Safety Monitoring

Maintaining in-house documents

Tracking of documents and activities

Archiving of documents

Study Close Out Visits.

Drug accountability.

CRF review

Query resolution

Phase III

Decompensate Chronic Hepatitis B

Global Study

05 sites &

42 Patients

October 2006--Ongoing

On site monitoring in compliance with the ICH-GCP and relevant SOPs

Assuring investigator’s adherence to protocol and GCP and initiate action to resolve issues during site monitoring visit.

Safety Monitoring

Maintaining in-house documents

Tracking of documents and activities

Drug accountability.

eCRF review

Query resolution

Phase III

Schizophrenia 05 to 07 Sites & 46 Patients

Start date:-August 2006

Stop date:-October 2006

Site monitoring visits and SDV.

Drug accountability.

eCRF review

Query resolution

Phase II Breast Cancer 04 07 sites & Patients 39 Start Date: October 2005

Stop Date: November 2006

Involved in responsibilities like:

Filing: Filing and maintaining in-house files.

Qc of all the regulatory documents on ongoing basis

Study Tracking: CRFs, Finance, Patient visit, SAEs, Controlled study documents, ICFs.

Preparing & Submission: News letters, SIV Kits, EC submission of controlled documents,

Completion of IP release check list.

Co-ordinating activities: Internal review for Translation of ICF for all sites.

Co-ordinating with the translation agency for finalizing and customization of translations and back translations.

Date(s) Subjects

25th 26th & 27th June 2008 CTL Launch Training

14 May 2008 Site Visit Report Reviewer Training

29 Feb 2008 Informatics-E-Briefcase Training

Informatics- SSU 2.0 Training

25 Feb 2008 Workshop on Problem solving and decision making

17 Feb 2008 How to Handle Inspection

15 Feb 2008 GCP refresher and updates

21 Jan 2008 Global Clinical Development Services (CDS) Strategy map.

28/11/2007

29/11/2007 Effective Presentations: The Presentation Process

26 Nov 2007 Effective approach to knowledge based monitoring

22/10/2007 Writing a corrective & preventive action Plan

15/10/2007 Managing Site recruitment

10/10/07 English – Business Ethics @ Quintiles

24/9/07 Skin and Skin Structure Infections

24/9/07 Schizoaffective Disorders

03/9/ 07 Site Selection Visits – a refresher

13/08/2007 Informed consent Form/Ethics Committee

06/8/ 2007 Introduction to Vaccines

23/7/ 2007 Workshop on Communicating Better

14/5/2007 Ischemic Stroke

05 /4/2007 Learning Curve

02/4/2007 Insurance and Indemnity

21/02/06 SOP Training: Site Visit Report & follow-up Reports

13/02/06 SOP Training: Site Monitoring Visit

06/02/06 SOP Training: Site Initiation Visit

03/02/06 SOP Training: Site Selection Visit

24/01/06 Electronic signature training for Informant 1.7 users

11/01/06 Introduction to ECG

10/01/06 Informant Electronic signature version 1.7

21/11/05

22/11/05

25/11/05 Personnel Effectiveness Training (Part 1 – 6)

14/11/05 CSID v5.4 All Staff Training (Basic User Access)

14/11/05 Essential Document Filing

08/11/05

09/11/05

10/11/05 ASV Training

27/10/05 SOP Training

25/10/05 SOP Training

21/10/05 Training on Therapeutic Area of Oncology.

17/10/05 Lotus Notes Training.

10/10/05 ERES: Basic Part 11 Awareness

10/10/05 Le Grand QUIZ- Laws, Regulations, Guidelines for Clinical Trials (Across Globe)

04/10/05

05/10/05

06/10/05

07/10/05

Orientation to Clinical Research.

29/09/05 CDS (Europe) – PDS Training: Module 1 – Project Management.

29/09/05 Signature Irregularities and Fraud – Self – Study.

29/09/05 Electronic data capture: An Introduction

28/09/05 Email Etiquette

27/09/05 Electronic Records and Electronic Signatures (ERES): Advanced Principles & FDA Guidelines.

19/09/05 HR Bulletin

16/09/05 CSID Interactive Training Guide.

Systems Experience/IT Skills

PC Skills

MS word

Excel

Power Point

Lotus Notes

Inntrax

Informant

Electronic data Capture (EDC) Inform and Remote Data Capture (RDC).

Other Relevant Details

Languages known :

 English (Read, Write and Speak)

 Hindi ( Speak)

 Urdu (Speak)

 Kashmiri (Mother Tongue)

Name : Aadil Manzoor Reshi

Father’s Name: Manzoor Ahmed Reshi

Martial Status: Single

Date of Birth : 01-02-81

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