FAISAL B A ZAIDI

E-** (Pvt) Saket

New Delhi -*7

Mobile +91-991*******

aczhpk@r.postjobfree.com

Strong ICH-GCP knowledge

Vendor selection

Problem Solving

Project Management

Project finance & budgeting

CRO-Oversight

Presentation Skills

Vendor Management

Team Management

TMF Management

Site Management

Daiichi Sankyo India Pharma Pvt. Ltd

Clinical Project Manager (Manager - Clinical Operations)

Jan 2013- Nov 2016

Role & Responsibilities

Support Clinical Study Lead (CSL) in ensuring all operational trial deliverables are met according to timelines, budget, procedures and quality standards, development of study tools, guidelines and training materials; management of clinical study material, implementation of issue resolution plan.

Currently working on Phase-I –Phase III studies

Global clinical study management

Review of monitoring report and study plans

Development of various study plans

Review and management of Trial Master File and Support CSL in the management of the trial master file

Oversight and management of Contract Research Organizations

Vendor management

Support in identification of CRO’s & vendors

Relationship management at internal as well as outside stake holders.

Review and provide input as needed to Protocol Profile, Study Protocol and Clinical Study Report

Support in audits & regulatory inspection & development of CAPA

Prepare clinical outsourcing specifications and manage vendors in collaboration with CSL.

Contribute to the development, management and tracking of trial budget working closely with the CSL and Finance.

In collaboration with CSL & Medical Lead, prepare training materials and presentations related to the planning and conduct of the trial and training of internal and external team members

Support CSL in management of trial allocation and coordination of activities leading to site initiation.

Support CSL by generating data cleaning reports and reviewing non medical data as assigned.

Write clinical trial team meeting minutes. Could deputize for the CSL at Clinical Trial Team meetings.

Responsible for implementation of best practices within global clinical operations.

Participate in the on-boarding, mentoring and training of new staff

Quintiles India

Sr. Clinical Research Associate-2

Apr 2012- Jan 2013

Kemin Pharma

Associate Manager –Clinical Operations

Jul 2011- Dec 2011

INC Research

Sr. Clinical Research Associate

Jan 2010- Jun 2011

Covance Pvt Ltd

Clinical Research Associate II

Oct 2007- Dec 2009

Chiltern International Pvt. Ltd

Clinical Research Associate II

May 2006- Sep 2007

Cogtest Services Pvt. Ltd

Clinical Research Associate

Sept 2005- May 2006

Role & Responsibilities

Perform Site Initiation Visit, Monitoring Visit & Close Out Visit as per Clinical Monitoring Plan, Monitoring Guidelines.

Coordinates production of clinical project plans and study designs in consultation with Project Manager/Project Director and any other relevant project team members

Negotiates clinical study costs and costs of other study related services with investigators and vendors.

Lead and manage the planning, implementation, monitoring and reporting of clinical studies within and therapeutic areas and a wide variety of clinical study types

Oversees management of study start-up, conduct & close-out and accountable to ensure all relevant studies follow SOPs & GCP requirements

Lead and oversee preparation of all study documents, including information sheet and Informed Consent documents

Proactively identifies potential recruitment challenges, develops innovative strategies to prevent recruitment shortfalls and drives implementation. Coordinates input from stakeholders.

Establishes interdependencies and timelines for clinical development plan, including tracking timelines, identifying contingencies and using risk planning to meet overall study goals.

Maintain timely and effective communication to global team members, sponsors and site staff, including routine, or as needed, study updates

Participation in development of clinical tools and study plans such as Clinical Monitoring Plan, & Monitoring Guidelines.

Trains & Mentor monitors on protocol, CRF and study specific procedures.

Regulatory Document Trackers and other various tracking systems to assess progress of site and team activities

Responsible for the implementation of standardized clinical monitoring processes within the Study and according to the applicable SOPs

Involvement in clinical resource management, assignment, delegation of clinical responsibilities and additional resource requirements

Apothecaries Clinical Research

Clinical Research Associate

April 2005 –Sept 2005

Cipla Ltd

Marketing Executive

April 2004 –Apr 2005

Zydus Cadila Health Care Ltd.

Trainee Business Officer

Jun 2003 –Dec 2003

Role & Responsibilities

Primarily involved in late phase studies (Phase IV)

Perform Site Initiation Visit, Monitoring Visit & Close Out Visit as per Clinical Monitoring Plan, Monitoring Guidelines.

Meeting Key Opinion Leaders and discuss scientific update about ongoing studies.

Support the marketing team in conducting CME and conferences.

Negotiates clinical study costs and costs of other study related services with investigators.

Lead and manage the planning, implementation, monitoring and reporting of clinical studies within and therapeutic areas and a wide variety of clinical study types

Oversees management of study start-up, conduct & close-out and accountable to ensure all relevant studies follow SOPs & GCP requirements

Lead and oversee preparation of all study documents, including information sheet and Informed Consent documents

Proactively identifies potential recruitment challenges, develops innovative strategies to prevent recruitment shortfalls and drives implementation. Coordinates input from stakeholders.

Maintain timely and effective communication to global team members, sponsors and site staff, including routine, or as needed, study updates

Oncology:

Advanced Pancreatic Carcinoma (Phase II), Antifungal in Oncology (Phase III) & NSCL (Phase II)

CNS

Schizophrenia (one Phase II and two Phase III), Fibromyalgia

Endocrinology:

Type II Diabetes Mellitus (Phase III)

Infectious Disease:

Two Urinary Tract Infections (Phase III)

Respiratory:

Chronic Obstructive Pulmonary Disease (Phase III)

Lean Six Sigma Green Belt program-

2016

KPMG India

Gurgaon (India)

Master of Business Administration (MBA)

Aug 10

IGNOU

New Delhi. (India)

Clinical Research Professional Development Program

Dec 2005

Kriger Research Centre (Online Course)

Canada

Course in Theory and Practices of GCP

Apr 05

Apothecaries Foundation

New Delhi. (India)

Advance Diploma in Management

Oct 12

AIMA

New Delhi. (India)

Post Graduate Diploma in Management

May 10

IGNOU

New Delhi. (India)

Diploma in Management

Feb 08

IGNOU

New Delhi. (India)

Bachelor of Pharmacy (B.Pharm)

Jun 03

Hamdard University

New Delhi. (India)

Publications

Role of Effective Project Management In Reducing Drug Development Cost"-Asian Journal of Pharmaceutical and Clinical Research" (Vol 10 Issue 3 March 2017)

“Translation Consideration for Initiating Global Studies” Oct 2008 “The Monitor” - a bimonthly journal of Association of Clinical Research Professional (ACRP)-USA.

“An Indian Perspective of Informed Consent Process” Oct 2007 “The Monitor” - a bimonthly journal of Association of Clinical Research Professional (ACRP)-USA.

“Indian Clinical Research Industry: Overcoming the barriers” June 2007 “The Monitor” - a bimonthly journal of Association of Clinical Research Professional (ACRP)-USA.

Award & Associations

“Spot Light Award ” for best team in Daiichi Sankyo India Pharma Pvt. Ltd in 2016

“Star Team” for best team in Daiichi Sankyo India Pharma Pvt. Ltd in 2014

“Team of the Year” for outstanding performance in the team in Daiichi Sankyo India Pharma Pvt. Ltd in 2014.

“Bravo Award” for performance excellence in Covance India Pharmaceuticals Pvt. Ltd in 2008.

Languages Proficiency

English, Hindi & Urdu

Date of Birth

3rd January 1981

Sex/Marital status:

Male/Married

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