Medical Clinical Research

**** ***** **** **** *****: ********.*********@*****.***

Toronto, L1X2L3 Mobile: 613-***-****

EXECUTIVE PROFILE

I am a result driven professional with experience in leading people and project teams, implementing and overseeing clinical research programs especially clinical trial and BA/BE studies. I possess an in depth understanding of regulatory guidelines emerging developments and applications in the Medical research domain. I also have experience of teaching in medical colleges and managing blood banks. Areas of expertise include project management, relationship and team building and crisis management.

SUMMARY

•Experience in regulatory submissions through CTD, eCTD

•Capability to retain result-focused approach in all clinical research activities under high-pressure situations.

•Meticulous project planning skills with ability to gather, analyze, organize and create concise action plans, research reports and presentations.

•Adept at working with senior management and/or business heads for decision support initiatives

•Open to new ideas for result oriented research activities

•Believe in team spirit with leadership quality and experience in working in a matrix

•Sound knowledge required for Assessment, RIAS conducting

•Experience with Risk Assessment, hands-on experience on ARGUS, BEERex and DEEM

•Have thorough understanding of USFDA, EU, EMEA, MHRA, ANVISA, Australia, Malaysia, Mexico regulations, GCP/ICH guidelines and clinical development process and also, faced their successful audits.

•Proficient computer skills to facilitate communications, track and manage projects Experience with Microsoft Office (MS Word, MS PowerPoint, MS Excel)

•Experience related to clinical operations, clinical trials, QA/QC, development of SOPs, staff development and training, resourcing staffing, and budget planning execution.

•Established a special population volunteer bank for clinical trials in special population groups.

•Experience in establishing a pharmacovigilance department in a hospital.

•Experience in development and maintenance of life-cycle documentation on assigned products

•Detail-oriented analytical and critical thinking

•Good Presentation skills with strong written and oral communication abilities.

•Effective negotiation and persuasive skills

•Experience in installing quality systems

•Bilingual fluent in English and Hindi

•Position holder in Deans’ Honor List twice

•Winner of the award for leader- team excellence

•

WORK EXPERIENCE

PHARMACEUTICAL ORGANISATIONS

Principal Investigator and Head Clinical operations Auriga Research Private Limited New Delhi, India

Nov 2016 - Aug 2017

Principal Investigator (Senior Research Scientist)

June 2009 - May 2013

Ranbaxy Research Laboratories Ltd.), India

Managed two units/sites of the organisation. Beside administrative work, my work included site management, budget management, Project development plan, project assessment, resource management, project implementation and planning.

Successful management of audits and inspections.

Served as a key collaboration contact with business partners, utilizing and protecting confidential information in compliance with established protocols

Performed source document verification (SDV), and query resolution in a timely manner and oversee drug accountability and safety at investigative sites getting approvals of projects on generic products for bio-availability/ bio-equivalence and Phase I studies.

Reviewed Investigator Brochures, study, safety and annual reports, SOPs and other documents; Coordinating with pharmacovigilance department, other clinical departments, internal staff, consultants and medical writers.

Conducted clinical activities and reviewed safety records and data on generic products for the submission to various International Drug Regulatory Authorities.

Implementation of Quality systems including clinical SOPs and GCP and GLP procedures.

Managed serious adverse events (SAEs) and liaise with safety departments to resolve SAE reporting issue. Submission of the final report of the trials to various International regulatory bodies.

Clinical Investigator (Senior Research Scientist) Jan 2007 June 2009

Ranbaxy Research Laboratories Ltd.), India

Designed protocols and trial master files.

Ensured safety of the subjects participating in the trials.

Managed the clinical research projects for their timely completion within budget, and in compliance with the applicable international guidelines and other applicable regulations, ICH GCP guidelines, and SOPs.

Site monitoring and preparation, SOP preparation and review.

HIV counseling of female volunteers, also training staff in BLS and HIV.

Supervision and maintenance of intensive care unit (ICU).

Managed serious adverse events (SAEs) and liaise with safety departments to resolve SAE reporting issue.

Worked as assistant professor, taking lectures and labs for MBBS, BPT and Nursing students and MD students, holding journal clubs and abstract club for post graduate medical students.

Also assisted in day to day administrative and departmental work.

Along with teaching, was also responsible for setting up of an animal house in the Medical College and getting the approval for the same.

Assisted in set up of the department of Pharmacovigilance in the college for reporting of adverse events

BLOOD BANKS

1.Senior Medical Officer & Blood Bank In charge Nov 2015 – Oct 2016

Government District Hospital Noida India

2.Medical Director May 2013 – Jan 2014

Rotary Blood Bank Noida, India

Besides the Administrative responsibilities, managed the Blood Bank by organising blood donation camps, procurement of instruments and other necessary equipment’s for the bank, recruiting qualified and trained staff are some of my responsibilities.

Also, initiated Thalassemia Awareness Program through presentations and Lectures at schools and colleges

OTHER WORK EXPERIENCES

Project Management of Pharmacokinetic Studies

Clinical Study Coordination of bioequivalence studies on generic drugs required for submission to various international regulatory as per GCP. Protocol, Informed Consent Forms, Case Report Form preparation in consultation with concerned department.

Quality Assurance

Overlooking implementation of Quality systems and managing the quality assurance department.

Successful resolution of Queries raised by the ethics committee or other regulatory bodies.

Medical Writing

Preparation of final clinical report as per the regulator requirement and GCP-E3 guideline

Preparation and designing of Trial Master Files, Protocols, Informed consent forms, Case report form, Investigational brochure, etc.

Food and Conference Services- Part -Time

Working part time at food and conference services of Algonquin college from November 2017 till date.

STRENGTHS

•Capability to retain result-focused approach in all clinical research activities under high-pressure situations.

•Meticulous project planning skills with ability to gather, analyze, organize and create concise action plans, research reports and presentations.

•Adept at working with senior management and/or business heads for decision support initiatives

•Open to new ideas for result oriented research activities

•Believe in team spirit with leadership quality.

EDUCATION

2017 -2018 Regulatory Affairs-Sciences Post Graduate certificate Algonquin College, Ottawa

Current GPA 3.7/ 4

M.D. Physician ECA: M.D. Pharmacology equivalent to M.D. (Doctor of medicine) Physician by Medical council of Canada

2003 - 2006 M.D. (Clinical Pharmacology)

(Doctor of Medicine-Clinical Pharmacology)

Himalayan Institute of Medical Sciences, Dehradun. India

1995 -2001 M.B.B.S. (Bachelor of Medicine, Bachelor of Surgery)

Himalayan Institute of Medical Sciences, Dehradun. India

PRESENTATIONS

•Presented a poster entitled "New generation of GABA enhancers as potential treatment for epilepsy" at International symposium on recent advances in pharmacology at Delhi 2004

•Presented a poster entitled "Prescription pattern of drugs used in neurological patients” at the annual national conference of Indian Pharmacological society. Chennai. 2005.

CERTIFICATES

•Good clinical Practice by NIDA (National Institute of drug abuse)

•Delegate and poster Presentation Certificate in 38th annual conference of IPS (Indian Pharmacological Society)

•Certificate of appreciation for paper presentation in Conference by Delhi Instirtute of Pharmaceutical science and research

•Participation in CME on diabetes by HIMS

•Presentation in symposium” International symposium on advances in Pharmacology “By Indian society of Heart Research

•Advanced cardiovascular life support (ACLS) by AHA

•Basic Life Support (BLS) Training by AHA

•Workshop on Basics of HIV /AIDS counselling as per NACO guidelines

•Certificate of Decision making and management

CONFERENCES

•North zone Conference of Indian Pharmacological Society, Delhi 2005

•Diabetes update 2004 by H.I.M.S. Dehradun.

•Attended 2 CMEs in Diabetes 2016

REFERENCES:

Ms Mary Baxter

General Manager

Food and Conference Services

Algonquin College

1385 Woodroffe Avenue

Ottawa ON K2G1V8

Phone: +1-613-***-****(5090)

Email: *******@****************.***

Prof. Wasif Islam

Algonquin College

1385 Woodroffe Avenue

Ottawa ON K2G1V8

Email: ******@****************.***

Prof. Thomas Conway

Algonquin College

1385 Woodroffe Avenue

Ottawa ON K2G1V8

Email: *******@****************.***

Dr. Manoj Karwa

Head Clinical Pharmacology Unit

Auriga Research Limited

Kirti Nagar

New Delhi

India

Phone: +91-931*******

Email: **********@**************.***

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