Educational Qualifications & Certifications

Highest Qualification

M.B.A/Post Graduate Diploma in Clinical Research (PGDCR).

GCP Certifications

E-Learning GCP from AGCP South Africa (Dec 2010).

Training Programme on “Clinical Research Monitoring” from Consortium Clinical Research in Ahmedabad in (Oct 2007).

Certification from BMS in GCP, ICF, Monitoring Responsibilities (Nov 2006)

SAS Certification

From SAS institute US,(Aug 2012)

Degree

Institution

Year

Post Graduate Diploma in Clinical Research

Institute of Clinical Research (ICRI), Delhi.

2005-2006

M.B.A

GJU, Hisar

2002-2005

Bachelors of Pharmaceutical Sciences

Hindu College of Pharmacy, Sonepat,

MDU University

1998-2002

Professional Experience Summary

Total Professional Experience

10 Years 7 Months

Experience in Clinical Research

7.0 Years 4 Months

Experience in Pharmaceutical Industry

3.0 Years

Project Management Experience

(Team Handling/Team Lead Experience)

4.0 years 8 Months

International Monitoring Experience

1.0 year (South Africa-Johannesburg)

Knowledge of Relevant Standards

ICH-GCP, Indian GCP/Schedule Y,

Systems/Softwares Worked On

Siebel, CTMS, Oracle, EDC,

Ellipsis, Citrix, e-Clinical, SAS 9..2

No. of Audits Faced

03 Audits (DCGI,MCC and Sponsor)

Therapeutic Areas Worked

Therapeutic Area

Indications

Organisation

Phases

Activities

Oncology

Gastric Cancer

Criterium, India

IIIb

Site Start-Close out.

Oncology

Pancreatic/Breast Cancer

Criterium, India

IIb

Feasibility

Pediatrics

Acute Otitis Media (AOMT)

Criterium, South Africa

III

Site Start- Closeout.

Oncology

Breakthrough cancer pain

i3 Research

III

Site Start up-Monitoring

Oncology

Breast and Pancreatic Cancer

i3 Research

III

Feasibility

Endocrinology

Type II Diabètes-

Oral Insulin

Synchron Research

III

Site Monitoring

Gynecology

Genital Candidiasis

Synchron Research

III

Site Start-Close out.

Endocrinology

Type II Diabètes-

Inhaled Insulin

Apollo Hospital

III

CRC

Neurology

Post Herpetic Neuralgia

(PHN)

Apollo Hospital

III

CRC

Current Position

Organization

Designation

From

To

Karmic Life sciences Pvt. Ltd

Assistant Project Manager

05 Nov 13

07 March14

Previous Positions

Organization

Designation

From

To

Criterium Clinical Research,Pune

Criterium Clinical Research,South Africa

Senior CRA (Project Lead Responsibilities)

Senior CRA (Project Lead Responsibilities)

Feb, 2009

Aug 2012

Oct, 2013

Aug, 2013

I3 Research (P) Ltd. Gurgaon

Senior CRA

Feb, 2008

Oct, 2008

Synchron Research (P) Ltd. Ahmedabad

Clinical Research Associate

Sep, 2007

Feb, 2008

Apollo Hospital (Spectra Clinical Research) Delhi,

Clinical Research coordinator

Nov, 2006

Sep, 2007

Micro Labs

Territory Executive

June, 2005

Aug, 2006

Torrent Pharmaceuticals

Medical Representative

Aug, 2003

June,2005

Current Roles & Responsibilities

Coordinate all project activities for assigned Phase I-IV clinical projects right from Project Team Selection and Training, Partner Qualification and Selection (SMOs, Central Labs, Translation Companies), Project Budgets and Timeline Planning, Site Initiation, Investigator Screening, Recruitment and Training, Patient Recruitment Oversight, Study Monitoring and Study Close-out

Plan or assist in conducting study start-up meetings

Monitor study progress to assure compliance with Protocol Requirements, ICH-GCP, DCGI and international regulatory guidelines and Sponsor SOPs

Monitor and track all project metrics including patient enrolment rates, study timelines (FPFV/LPLV) and study budgets as per project plan

Mentor and train CRAs and CTAs

Perform co-monitoring to ensure adherence to protocol,SOPs and regulatory requirements

Ensure timely, accurate and complete collection, completion and filing of study data

Identify, address and resolve issues and problems as they might occur at study completion

Maintain audit readiness at the site level for any audits or regulatory inspections

Lead feasibilities of various therapeutic segments.

Identification of new potential investigators/ sites in various therapeutic areas

Key Trainings Attended

Training Name

Date

Trainings on Clinical Research Monitoring

Oct 07

BMS Certification in GCP

Nov 06

AGCP Certification in GCP

Dec 10

Personal Details

Date of Birth

14 March 1980

Marital Status

Married

Nationality

Indian

Languages:

English, Hindi

Correspondence Address

1005, EM-1, BDI Alwar Bye pass Road, Bhiwadi, 301019

.

Permanent Address

1005, EM-1, BDI Alwar Bye pass Road, Bhiwadi, 301019

Personal Details

Declaration

I hereby declare that all the information given above is correct to the best of my knowledge.

Alok Miglani

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