MR. SHARDUL KULKARNI

Contact No: 0044 – (0)7859035489. E-Mail : shardulkulkarni27@gmail.com Indefinate Leave to Remain (ILR) in UK.

CAREER OBJECTIVE

Being a Qualified Pharmacist, and with a strong experience of Pharmacy and clinical trials (Commercial and Non-commercial) in NHS, I would like to work in a creative and challenging environment, to build a prospective career in the versatile Pharmaceutical and Clinical Research Sector involving various Information systems in, Project Management Clinical trials, Drug Safety, Pharmacovigilance by giving my best to the organization towards success.

Experience and Knowledge of Clinical Trials

Working as primary contact between the CRO/CRA’s, NHS Research team and Pharmacy team.

Conducting Pre-SIV Meetings and training sessions, SIV’s, Follow-up Monitoring Visits, remote monitoring visits and close-out visits for commercial and non-commercial trials.

Working knowledge of the governance and legislative framework for conducting clinical research studies, including GCP, MHRA regulations, IRAS and current national systems and their structure for the approval, management and monitoring of clinical research in NHS.

Negotiation skills and ability to analyse interpret and communicate complex information logically to develop and implement local management systems.

Sound knowledge and experience of financial and project management within NHS

Preparing and maintaining the Trial Master File (TMF), Clinical Trials Pharmacy Site File (PSF) with the documents provided and locally produced and approved documents, like, Trial Specific Pharmacy Procedure (TSPP), Worksheets for Aseptic trials, Local Inventory documentation and various other site management documents

Recruitment, interviewing of junior staff, in the department, training of the assistants, pre-registration pharmacists, student technicians and other new staff in clinical trials.

Knowledge of Drug Safety and Regulatory Affairs

Clear Understanding of agency guidelines relating to regulatory submissions for both paper and electronic submissions to ensure that documents are formatted in a way to meet these requirements.

Understanding of processes and documentation to ensure the accurate compilation of new license applications, involving the maintenance of document templates, updating internal procedures following updates to agency guidelines.

To request documentation from internal and external bodies to support registration applications.

Assemble process and maintain original registrations, amendments (Substantial and No-substantial), supplements, variations, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements and guidelines in relation to the Clinical Trials Protocols and IB’s. This activity includes chasing up local and regional submissions as applicable, such as MHRA REC Approval and Local R&D approval, EVMPD (EMA) and Structured Product Labelling (FDA) from concerned stakeholders involved.

Personal Skills Enthusiastic, organized, well-mannered with good communication and interpersonal skills, essential to exchange highly complex information to colleagues, patients and relatives, clinicians, CRA’s and senior managers (both within and outside the Trust).

Adaptable to team work to achieve the set time bound targets by strategic and operational high degree of emotional intelligence.

Capable of taking a lead wherever essential and advisable with analytical, problem solving and logical skills by prioritizing the work load.

Innovatory and implementation skills to develop services in accordance with accepted standards.

WORK EXPERIENCE:

Since April 2015 Job Responsibilities: -

Kings College Hospital NHS Foundation Trust, Denmark Hill, London, UK. Senior Pharmacy Technician – Clinical Trials. Currently working in a big Clinical Trials department at Kings Pharmacy, with approximately 400 currently running trials (Commercial/ Non-commercial) and approximately 180 trials in set-up. Involved in both Dispensary and Aseptic trial setup and day to day monitoring within pharmacy for commercial and non-commercial trials ranging in Oncology, Haematology, Liver, neurological, etc.; Involved in following day to day activities –

Create critical Clinical trials project documents for Pharmacy Site File (PSF) like Trial Specific Pharmacy Procedure (TSPP), patient ID logs, Delegation and accountability logs, procurement procedures, dispensing and sample labeling guidelines, destruction procedures, based on protocol, source documentation forms/guidelines,

Liaise with the CRA's/ Trial Monitors during their monitoring visits (both site and remote) to confirm the protocol compliance with GCP compliance, Identify any site issues, initiate authenticate corrections as per the monitoring visit reports and to resolve site issues and facilitate project timelines.

Ensure subject safety, storage requirements, completion of delegation and accountability logs (Master/ Subject/Drug specific), reporting temperature excursions, and appropriate destruction processes are followed and duly reported as per the set guidelines for the individual study.

Conduct monitoring and close-out visits with the CRA's and lead pharmacist to ensure the complete reconciliation of the PSF by requesting any new and updated site related essential and non-essential documents, review their contents, consistency with other referred documents and compliance with the appropriate local regulatory requirements, ICH guidelines, TSPP, and sponsors requirement.

Collect and verify the essential data by assessing the accountability logs, procurement paperwork and paper and/or online data management portals/ websites to make sure the data in correct, secure and confidential to allow the sponsors and the CRA to access the same when required.

Provide Training and assessment to the new starters and junior staff coming to the clinical trials department following the data protection and confidentiality of the individual studies.

Involved in the recruitment process of senior assistants and assistants, including, shortlisting from the applications, interview questionnaire and mathematical/logical test preparation and interviews.

Clear in-practice understanding of Good Manufacturing Practice [GMP], Orange Guide, Farwell Report, Control of Substances Hazardous to Health legislation, National Aseptic Services guidelines. Medicines and Healthcare products Regulatory Agency [MHRA], Department of Health's Research Governance Framework, HRA approval Process, EU trial regulations and licensing guidelines and standards.

From July 2014 to April 2015 Job Responsibilities: -

North Middlesex University Hospital Trust, London, UK. Senior Clinical Trial - Pharmacy Technician.

Liaison with Clinical Research Associates and research staff for start-ups, Maintenance, audits and close-downs of clinical trials to Unify the trial specific, information, procedures and documentation across the

Contact for NCRN and commercially approved clinical trials within NMUH, accordingly set-up trials into the chemo-care electronic prescribing system in collaboration with medical and pharmacy staff.

Liaise with oncology and haematology clinic nursing staff and research teams to identify trial patients and facilitate the dispensing of their treatment with maintenance of accurate trial documentation.

Maintain personal aseptic techniques for reconstitution of cytotoxic and carry out Environmental Physical and Microbiological monitoring of the clean rooms and lobby of the Production Unit.

From Sept 2009 –June 2014 Job Responsibilities: -

North Middlesex University Hospital Trust, London, UK. Rotational Pharmacy Technician.

Completed 3 rotations in each section of Pharmacy – In-patients, Out-patients, Controlled Drug Room, Stores/Distribution department, Procurement Department and Aseptics. Gained extensive experience in local and national day- to – day working policies of Pharmacy department within NHS.

This has enhanced my knowledge in Dispensing, Stock Control and Procurement, Formulary and Non-formulary drug management, Medicine Management for patients on wards and in clinics, aseptic techniques for chemotherapy and immunoglobulin preparations in clean room environment.

Nov 2008 – Sept 2009

North Middlesex University Hospital Trust, London, UK. Senior Assistant Technical Officer (SATO). After extensive experience in community pharmacy, got an opportunity to start my career in NHS. This enhanced my knowledge in hospital pharmacy departments like, out-patients, in-patients, distributions and procurement and HIV medicines.

Sept 2007 – Nov 2008

Boots, The Chemists, Twickenham / Hounslow, Middlesex, UK Pharmacy Dispenser.

Sept 2006 – Sept 2007

Co-op Pharmacy (National Co-operative Chemists), Stevenage, UK. Pharmacy Assistant and Dispenser.

Jan. 2004 - July 2004

Pharmaceutical R & D, Formulation, Pfizer Ltd., Mumbai, INDIA. Management Trainee.

July 2003 – Dec. 2003

Product Promotion and Marketing,Sandoz Pvt. Ltd., Sante Pharma, Pune, INDIA. Brand Promoter.

ACHIEVEMENTS:

Professional Achievement

Designing and implementation of Monthly Finance Accounting System for more than 200 clinical trials run in the department at Pharmacy at Kings College Hospital.

Renewal and Improvements of all the training documents within department.

Successful Lead Procurement and Distribution Accreditation.

Introduction of new Personalised Bar-code ID Cards to all the pharmacy staff, to help set-up new live prescription tracker system in Pharmacy department.

Supporting the ward Pharmacist in the provision of medicines management according to NMUH departmental policy

Event Management

Involved with a non-profit charity organisation - Maharashtra Mandal London as Vice-President (EC current term 2015-17), an Program Organiser (PO) and Public Relation Officer (PRO) in term 2012 to 2014) and Head of Film and Drama Committee for the committee term of 4 years (2010- 2012 and 2012 to 2014).(www.mmlondon.co.uk)

Enthusiastically involved in Stage Designing, production; and various other management aspects for big events at O2-Indigo, Wembley Arena, and Wembley Stadium.

Founder Prismatic Pictures – Photography and Videography services for small events and parties since 2008

Dhol Beats UK – Unique and only Traditional Maharashtrian Dhol (Drums) band in UK performing at different event in UK. The biggest event the band performed was at Wembley Stadium in honour of the Indian Prime Minister during his visit in November 2015, in presence of Honourable Prime Minister of UK and 70,000 audiences.

Graduation level Class representative in Final Year B.Pharm, Editor of Scientific Section of College Annual Magazine], and college representative at 54th Indian Pharmaceutical Congress, Pune, India.

Played as Team Captain in School for District Kabbadi Interschool Competitions and further in Maharashtra State Pharma Kabbadi and Cricket Competitions during Bachelors for 3 years.

Interests Painting, Reading, Soft Classical Music (Traditional Dhol, Tabla, Keyboard)

REVIEW PROJECTS: Completed extra-curricular assignments during graduations with seminars on their completion.

Project Title: Review on Novel Methods of Contraception.

Project Title: Evaluation of hydration effect on lubricant efficacy of magnesium stearate.

Project Title: GENETIC MEDICINE - The Pathway along 21st Century.

EDUCATIONAL QUALIFICATION:

Masters :- Post-Graduation in Pharmacology 2007 Class Obtained. Subject of Interests

University Of Hertfordshire, UK. School of Life Sciences, University of Hertfordshire, United Kingdom. Secured Higher Second Class. Successfully studied following modules with practical applications – Core Pharmacology, Core Molecular Biology, Molecular Medicine, Molecular Pharmacology and drug Development.

Graduation:- Bachelors in Pharmacy in 2003 Class Obtained. Industrial Training Subject of Interests

University Of Pune, Pune. R.D’s College of Pharmacy, Bhor, Pune, India. Secured First Class At Eclat Pharma & Aerosols Pvt. Ltd., Graduate Voluntary Trainee for 3 months to fulfil the requirement for Bachelors Degree. Pharmaceutics, Pharmacology, Medicinal Chemistry, Drug Studies and Business Management, Pharmaceutical marketing and Jurisprudence, Elements of Biostatistics and Calculus, Pharmaceutical engineering.

OTHERS QUALIFICATION:

Diploma in Project Management 2016 Modules –

Advance Learning Interactive Systems Online (Alison), Galway, Ireland. Free online course with Paid Certification Project Management (PM) Overview, Methodology, Toolset, , documentation, System Development Life Cycle (SDLC), Planning, Feasibility Analysis, Design, Implementation, Use/Evaluation phases, PM case studies, involving IT, Toolset, GANTT Charts documentation and conclusion assessments.

GCP & the Medicines in Human Use (Clinical Trials) Regulations 2016 Modules :-

Kings Health Partners Clinical Trials Office, Kings Health Partners. Introduction to clinical trials, Good Clinical Practice (GCP), Regulations in UK and world.

Training for Capability 2015 Modules :-

London Pharmacy Education and Training Tutoring, Coaching and Training skills using Self Directed Learning (SDL), Bloom’s Taxonomy, Competence v/s Confidence model, and Grow Model.

Diploma in Information Technology in 2002 Grade Obtained. Modules :-

Mitcon-e School, C-DAC, Pune, INDIA. Secured A- Grade (74.34 %) Windows 98, MS-Office, MS-Dos, Internet Basic.

REFERENCES: Available on Request. Place: Hounslow, UK.