Shardul Ghugari

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.

• 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.

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.

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.

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.

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.

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.

Pharmaceutics, Medicinal Chemistry, Pharmacology, Biopharmaceutics, Quality Assurance Techniques

This was a 4 year professional degree program which equipped students with skills to enter the booming pharmaceutical industry in India and also to enter specialized post graduate programmes.