Clinical Research Management

CURRICULUM VITAE

ADITYA SHARMA

DOB: ** DECEMBER 1987

2068A, HBC, MALE, Sector-3, Faridabad, Haryana

E-MAIL: ***********@*****.***

PHONE: +91-964*******,+91-991*******, +91-129-*******

PROFESSIONAL DETAILS:

Registered with Indian Pharmacy Council

CAREER OBJECTIVE:

To be a part of good organisation, that encourages professional growth through wide range of

challenging assignments, which would use my skills and knowledge to become a successful

professional with reputation and recognised by the profession for expertise and knowledge.

PROFESSIONAL EXPERIENCE:

• Having experience of 2.5 years in clinical trials.

• Site selection, Site initiation,site management and investigator

undertaking, site monitoring visits.

• Presently working with RANBAXY Laboratories Ltd., Gurgaon

(Haryana) as clinical research associate and handling Phase 4 and Phase 3 trials.

• Detailed knowledge of ICH-GCP including basic understanding of

regulatory requirements.

• Earlier worked as a clinical research coordinator (Post Graduation Intern)

at the Apollo Oncology Centre, Indraprastha Apollo Hospital, New Delhi handling phase 3

trialswith following job responsibilities.

Coordinating site initiation visits.

Submission of study protocols to ethics committee for approvals and

all pre-study documentation requirements.

Assist Principal Investigator in patient selection and clinical research

study.

Investigational Product accountability and dispensing.

Scheduling patient visits and follow ups.

CRF Completion.

Assuring adequate reporting of adverse events.

Prepare study status reports.

Maintain study files on an ongoing basis to ensure that the files are

complete and can be used as a source of reference.

Ensuring that serious and non-serious adverse events have been

recorded and reported in accordance with relevant SOPs.

Manage the delivery of clinical study protocols, clinical study

reports, study agreements, applications and other study documentation.

Train internal and external study personnel in study specific

procedures.

Develop detailed study outlines and ensure medical and scientific

input in study reports.

Assist in non-project work and the development of clinical R&D

procedures.

EDUCATIONAL QUALIFICATIONS:

YEAR DEGREE INSTITUTION DIVISION

2011

POST GRADUATE

CERTIFICAT COURSE INDRAPRASTHA APOLLO

1st

IN CLINICAL HOSPITAL, DELHI

RESEARCH

INDRAPRASTHA APOLLO

2011 INTERNSHIP / TRAINNING

HOSPITAL, DELHI (Apollo Hospitals

Research Foundation, New Delhi)

2010 B.Pharma. Dr. K N Modi Institute of Pharmaceutical

Education and Research, Modinagar, U.P.

1st

2003 Secondary CBSE

1st

1st

2005 10+2 CBSE

PROFESSIONAL QUALIFICATION:

POST GRADUATE CERTIFICATE

COURSE IN CLINICAL RESEARCH – completed recently from Apollo

Hospitals Research Foundation, New Delhi

Modules Offered:

Module 1: Drug Development

Module 2: Pharmacokinetics & Therapeutic Drug Monitoring

Module 3: Phases of Clinical Trials

Module 4: Role of Ethics in Clinical Research

Module 5: Basic Statistics and Research Methodology

Module 6: Record keeping, Writing Reports and papers

Module 7: Drug Regulation and Drug Laws in India and abroad

Module 8 : Laboratory Investigations

Module 9 : Clinical Trials Finance

Module 10: Management of a Clinical Trial at a site

Module 11: Clinical Trials Finance

Module 12: Data Management in Clinical Trials

Module 13: Clinical Trials in Children

Module 14: Drug Reaction / Interaction / Information / Poisoning

Module 15: Audits and Inspections

Module16:Newer Approaches in Drug Research and Development

Trials handled:

Internship / Training from Indraprastha Apollo Hospital

(AHERF), Delhi handled trials in areas:

1. Neurology

2. Oncology

3. Vector born diseases.

One month vocational training in Psychotropic India Ltd.,

Faridabad (Haryana) (Production field).

EXTRA CURRICULAR ACTIVITIES:

Active participation in Dr. K.N. Modi foundation sports Meet

ZEAL 2007.

Participated as shot put player at state level in year 2003

KEY STRENGTHS:

Hard working and eye for detail

Ability to work under dead- lines and deliver

Adaptability

Excellent organisation, planning and problem solving abilities.

Excellent interpersonal and communication skills.

Knowledge on internet, Microsoft word, Microsoft Power Point.

PERSONAL DETAILS:

Gender : Male

Languages known : English, Hindi

Marital Status : Single

Father’s name : Sh. P. S. Sharma

Nationality : Indian

REFERENCES:

• Dr.R.K. Roy

Director

Dr. K. N. Modi Institute of Pharmaceutical Education & Research, Modinagar,

Ghaziabad (UP).

• Proff. V S Mathur ( pharmacologist)

Coordinator

ApolloHospital Education And Research Foundation,

Indraprastha Apollo Hospital

New Delhi-110076

Mobile-981*******

• Dr Vibha Dhingra

Indraprastha Apollo Hospital,

New Delhi -110076

Mobile - 981-***-****

I hereby declare that the information provided above are true to the best of my knowledge

and belief.

ADITYA SHARMA

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