Work History

Work History
Sep 2014 - Present

Global Study Manager

Roche UK
Mar 2013 - Apr 2014

Clinical Study Manager

GSK
Sep 2012 - Feb 2013

Clinical Study Manager

BTG Plc
Aug 2010 - Aug 2012

Global Study Manager

i3 Research

Pharmanet/i3 is a world leading clinical research organization (CRO) with annual revenue of $900 million and more than 6,000 employees dedicated to clinical research in more than 30 countries.

  • Coordinate the activities and deliverables of all study conduct partners
  • Oversee Country Offices to ensure that Protocol and Monitoring Plan are implemented across investigator sites and countries.
  • Ensure operational aspects of a clinical study meet time, quality & cost targets consistent with the Clinical Development Plan.
  • Manage study management components of protocol level budget.
  • Liaise with Data Management and protocol team in the design of data capture tools, review and approval of database design.
  • Conduct country level allocation including country and study level feasibility assessments to ensure appropriate country and study site selection.
Nov 2009 - Jun 2010

Clinical Research Co-ordinator

Milton Keynes General Hospital
  • Work exclusively on CSP-ReDA and NIHR portfolio for adopting studies for the Hospital.
  • Promote and facilitate the adoption of UKCRN portfolio studies within the Trust, with particular attention to non-research active areas, within the current framework of local and national guidelines and protocols and UKCRN requirements.
  • Support clinicians in initiating commercial and other trials, and will provide detailed advice on research policy and procedure.
  • Provide support and specialist R&D advice to investigators to ensure that studies are successfully set up and opened to recruitment, and will be responsible for the co-ordination, and the resolving of issues relating to research studies.
  • To assess the feasibility of conducting new and potential clinical trials and research studies, e.g. financial implications, human resources, infrastructure, equipment needs with appropriate staff including Consultants, Departmental Heads (e.g. Radiology, Pathology, Pharmacy), Research Nurses, Specialist Nurses and the R&D budget holder.
Dec 2007 - Jul 2009

Site Manager

Bristol-Myers Squibb Company

With over 40,000 employees and $19.3 billion in sales, BMS is arguable the most sought after pharmaceutical companies to work with.

Project Management of Phase II-III trials

  • Clinical Trial execution from pre-study evaluation to site close out.
  • Conduct feasibility of global multicentric studies.
  • Conduct data management of investigator site’s data, identify trends and generate data clarifications forms and control data clean-up issues.
  • Regular and continuous training of CRAs’ on ICH-GCP and study specific training and activities/tasks.
  • Budget negotiation with sites and Contracts finalization.
  • Work in collaboration with data manager and CRA to achieve database lock.
  • Planning and conducting study specific training workshops during the course of the trial.
  • Supervise study initiation visits in collaboration with Clinical Research Associates.
  • Assess overall investigational site performance & work with CRA to take appropriate measures to ensure optimum site performance.
  • Ensure investigators compliance with the study protocol, ICH-GCP, FDA Regulations, CFR, Company SOPs and all applicable regulatory requirements.
  • Regulatory submission and ensuring approval of CTA (Clinical Trial Application) from regulatory authorities
  • Vendor management.
  • Training of mentees and new recruits.
  • Conduct and host Investigators Meetings.
Mar 2005 - Dec 2007

Clinical Research Associate

ClinInvent Research Private Limited

Employment Status: Permanent

ClinInvent - A full service CRO with a well trained and experienced team with global network.

Worked as a CRA on Pfizer global projects exclusively

  • Perform study site selection and pre-study visits with support from Manager.
  • Co-ordinate with data management teams and investigator sites for generation and resolution of data clarifications forms and other data clean-up issues.
  • Responsible for regular and continuous training of site study personnel on Good Clinical Practice and study specific activities/tasks in co-ordination with Clinical Study Manager.
  • Assist Clinical Study Manager in planning and conducting study specific training workshops during the course of the trial.
  • Conduct study initiation visits in collaboration with Clinical Study Manager / Line Manager.
  • Conduct monitoring visits per specified timeframes at all assigned sites.
  • Assess overall investigational site performance & take appropriate measures to ensure optimum site performance.
  • Ensure investigators compliance with the study protocol, Good Clinical Practice, Company SOPs and all applicable regulatory requirements.
  • Attend Investigator Meetings.
Apr 2003 - Mar 2005

Territory Business Manager

Nicholas Piramal India Ltd

Employment status:Permanent -

Health & Pharmaceuticals

Nicholas Piramal India Limited is one of India's largest companies with a proven commitment to IPR. NPIL had a consolidated net sales turnover of US$ 413 million in 2006-07.

Speciality sales of Cardiology products

  • Achieving sales target budgeted for the year.
  • Liasioning with Doctors, Hospitals and generating prescriptions.
  • Effective launch of new products by announcing schemes and other allied inputs.
  • Sales promotion activities.
  • Providing market feedback on competition regularly.
  • Getting orders and follow-up orders and payments from stockists.
Aug 2000 - Mar 2003

Medical Representative

GlaxoSmithKline Pharmaceuticals

Employment status: Permanent

Health & Pharmaceuticals

Headquartered in the UK and with operations based in the US and worldwide, we are one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market.

Specialised in sales of general pharmaceuticals

  • Achieving sales target budgeted for the year.
  • Liasioning with Doctors, Hospitals and generating prescriptions.
  • Effective launch of new products by announcing schemes and other allied inputs.
  • Sales promotion activities.
  • Providing market feedback on competition regularly.
  • Getting orders and follow-up orders and payments from stockists.

Skills

Skills

Global Study Management

Project Management

Clinical Trials Phase II-IV, Clinical Site Management, Site Monitoring, Vendor management, budget negotiations and contract finalisations.

Electronic Data Capture Systems

MHRA Regulations

CSP-ReDA

ICH-GCP

Documented ICH-GCP training by Academy of Clinical Excellence (ACE) at Bombay College of Pharmacy (BCP), Mumbai.

MS Office

Well versed with the use of MS office package i.e Outlook, Powerpoint, Word, Excel.

Language - English

English language proficiency TOEFL (Test of English as Foreign Language) iBT (internet Based Test) score of 104 marks with 24+ marks each in all sections viz; Listening, Reading, Speaking and Writing.   NELTS (National English Language Testing Service) - Grade B - Good. The NELTS test is prepared by a team of specialists at CIEFL (Central Institute of English and Foreign Languages), and administered by Orient Longman Limited, the official associates of CIEFL.

India Regulations - Schedule 'Y'

These are a more refined version of ICH-GCP and are set forth as a law by MoH (India) for conducting clinical trials in India.

Education

Education
Apr 2007 - Oct 2008

Post Graduate Diploma

Academy of Clinical Excellence affiliated to Bombay College of Phamacy

Ethics in Clinical Research, Data Management, Clinical Monitoring, Clinical Trial Project Management

This was a 6 month part-time industry oriented program for working executives who wanted to further hone their skills in Clinical Research. I attended this course as a sponsored candidate by Pfizer. This course involved various activities and assignments including projects based on real scenarios which we face every day in clinical research.

Other Personal Details

Date of Birth:        19-Mar-1979

Gender:                Male

Marital Status:      Married

Driving Licence:  UK Driving License

Visa Status: Valid work permit to work in the UK (Tier 1 General)

Personal Interests

Table Tennis, Quizzing, Internet surfing, watching television commercials, meeting new people from different countries

Associations

Indian Society of Clinical Research - www.iscr.org

Since: Aug-2006 Until Dec-2009

Achievements

  • Successfully closed 5 data snapshots of 2 global multicentre oncology trials responsible for 6 countries.
  • In UK, was able to reduce study start up time from 75 days to a healthy 40-45 days in the hospital by active follow up with different departments.
  • Extensive clinical monitoring experience in India.
  • Therapeutic knowledge of:
    • Bipolar mania.
    • Schizophrenia.
    • Non-small cell lung cancer.
    • Breast cancer
    • Psoriasis.
    • Malaria.
    • Growth hormone deficiency.
    • Asthma.
    • Paediatric pulmonary arterial hypertension (PAH).
    • Colorectal Cancer.
    • Diabetes
  • As a CRA, conducted close to 170+ monitoring visits and retrieved close to 6000+ CRF and e-CRF pages as a CRA in a span of 30 months.
  • Conducted close to 30 site selection visits in a span of 3 months.
  • Monitored 15 global trials at 22 sites till date.
  • Worked exclusively on 5 type 2 diabetes trials with short recruitment time and large recruitment target.

Profile

  • Valid work permit (Tier 1, General Migrant) to work in the UK.
  • 7 years of experience in Clinical Research (UK and India).
  • 4 years Global Study Management experience in Oncology and Speciality Care. 
  • 3 years of experience in clinical site monitoring of Phase II-IV trials in Oncology, Infectious diseases, Respiratory diseases, Psychiatry.
  • UK clinical research experience includes source data verification (SDV) of patient files, working on Research Governance Framework by NIHR.
  • Up to date ICH-GCP (UK) training certificate by Royal Holloway, University of London in Jan 2010.
  • Extensive database experience on CSP-ReDA and NIHR Portfolio studies.
  • Extensive experience of working on 3 world class EDC/RDC systems viz; I*NET (Pfizer internal system), InForm® (EDC from Phase Forward) and the most widely used OC-RDC (Oracle Clinical - RDC®) system.
  • Extensive experience of working on IMPACT® system for Project management from Perceptive Informatics, UK.
  • Other global online system experience include QNET, IMPALA, RIVRS etc.

Licenses & Certifications

Registered Pharmacist (No.56262)

Issuer: Indian Pharmacy Council - Maharshtra State

Valid: 16-Oct-2000 to 01-Aug-2018