Manager Sales

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Shardul Ashok Ghugari References

B.PHARM, PGDCR

(Superior)

Joanna Gibbs

Global Study Manager

i3 Research

(Superior)

Kathleen Hunter

33, Checketts Close m: 077********

Leicester LE4 5EU

United Kingdom

(Superior)

Amit Gulwadi

*******.*******@*****.***

Linkedin Profile: http://uk.linkedin.com/in/shardulghugari

Dr.Chandrashekar

Profile Potkar

(Superior)

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.

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.

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Work History

i3 Research

Leicester, Other, United Kingdom Aug 2010 - Present

Global Study Manager

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.

Swiss Precision Diagnostics GmBH

Bedford, Other Jul 2010 - Aug 2010

Clinical Research Associate

SPD was formed in 2007 as a joint venture between Procter & Gamble (P&G) and ALERE to create,

using its parent companies complementary strengths, one of the world s foremost organisations in

consumer diagnostics. SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the

research, design, production and supply of advanced consumer diagnostic products.

Worked on PERSONA device development

Protocol writing

Study Monitoring Plan

Vendor Management

Milton Keynes General Hospital

Milton Keynes, Other, United Kingdom Nov 2009 - Jun 2010

Clinical Research Co-ordinator

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,

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equipment needs with appropriate staff including Consultants, Departmental

Heads (e.g. Radiology, Pathology, Pharmacy), Research Nurses, Specialist

Nurses and the R&D budget holder.

Bristol-Myers Squibb Company

Mumbai, India Dec 2007 - Jul 2009

Site Manager

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.

ClinInvent Research Private Limited

Mumbai, India Mar 2005 - Dec 2007

Clinical Research Associate

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.

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Nicholas Piramal India Ltd

Aurangabad, India Apr 2003 - Mar 2005

Territory Business Manager

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.

GlaxoSmithKline Pharmaceuticals

Ahmednagar, India Aug 2000 - Mar 2003

Medical Representative

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

ICH-GCP (Advanced)

3-4 Years Experience, (Last Used 3-4 years ago)

Documented ICH-GCP training by Academy of Clinical Excellence (ACE) at Bombay College of

Pharmacy (BCP), Mumbai.

Project Management (Advanced)

5-6 Years Experience, (Last Used 3-4 years ago)

Clinical Trials Phase II-IV, Clinical Site Management, Site Monitoring, Vendor management, budget

negotiations and contract finalisations.

CSP-ReDA (Intermediate)

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