Dr. AMOL S.

KSHIRSAGAR
Mobile : +919923642164
E-mail : [email protected]

OBJECTIVE:
To achieve challenging position in Research organization that is devoted to finding better treatment,
diagnosis &prediction of complex human diseases, which will utilize my professional skills & abilities
in impacting the success & growth of organization in becoming & sustaining its reputation a leader
in clinical research & pharmaceutical industry.

SUMMERY OF QUALIFICATION
Clinical research professional, over 6 yrs experience in Global Clinical Trials and extensive experience
over 10 years in Medicine and has been certified in clinical research by Institute of Clinical Research,
UK and ICR Mumbai. Currently, working as Research Officer at K.E.M. Hospital Research Centre Dept.
of Cardiovascular Research with emphasis on Global Clinical Trials on Cardiovascular, Drug Eluting
stent device, Diabetic , Nephrology clinical trials and presently working on Phase, II, III, IV studies.
With Responsibility of, project management, drug safety, to ensure safety of clinical trial subjects
along with clinical trial is conducted in adherence with ICH GCP guidelines protocol and sponsors SOPs,
mentoring colleagues .Experience as guest faculty at different clinical research institutes.
SKILLS:
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e.
ICH GCP, relevant local regulation and guide lines in clinical research.
Familiarity with related system software utilized in clinical operations, including MS office.
Good planning, time management and prioritization skills.
Good therapeutic and protocol knowledge.
Results and detail-oriented approach to work delivery and output
Good understanding of medical terminology.
Ability to handle conflicting priorities
Attention to detail and accuracy in work
Good organizational and project management skills
Results and detail-oriented approach to work delivery and output
Proven ability to work on multiple projects balancing competing priorities
Ability to establish and maintain effective working relationships with coworkers, managers and sponsors
EDUCATIONAL CREDENTIALS

P.G.Dip.Clinical Research ICR Mumbai, Campus. IstGrd March 2009

PROFESSIONAL AFFI LATIONS / MEMBERSHIPS.

EMPLOYMENT DETAILS:
Research Officer K.E.M.HospitalResearch Centre Since May 2010
Research Fellow Nutri International July 2007 - Apr2010
Medical Officer Radhika Hospital, Phaltan Jan 2004 - Jun 2007
Resident M.O. Swami Samarth Hospital Aug2002 - Dec2003
Assist. Doctor Dr.Jeurkar Clinic Jan2002 - Jul2002
MEDICAL PRACTICE:2004 ongoing
MEDICAL INTERNSHIP Duration: Jan 2001 to Jan. 2002
TRAINING OBTAINED GCP TRAINING 2014 Certified medidata professional.
Regularly obtained Protocol Specific Training during SIV &IM
Attended CMEs as part of continuing medical education at various Hospital
Regularly obtained GCP training during SIV and Investigators Meeting.
Attended FDA smart compliance program on regulatory affairs & safety reporting.
SEMINAR: Presented seminar on Pharmaco Economics Studies as part of course assignments.
AUDITS FACED: Sponsor audits (thrice in 5 years)
ACHIVMENTS : Crucial part of the successful team in facing sponsor audits
Active Participant of Excellent Team Award
CONFERENCE : Investigators Meeting at Jaipur- project ******* FEB 2013
Investigator Meeting at jaipur project ******* DEC 2012
Investigators Meeting at Mumbai project ********* JUL 2012
Investigators Meeting at Bangalor- project ****** JAN 2012
Investigators Meeting at Delhi project ******* 2011
Investigators Meeting at Cochin - project ******* 2011
Emergency Medical Services & Basic Life Support conducted by Ruby Hall Clinic.
Trial Experience:
Project **** Non-Valvular Atrial Fibrillation phase III Research Officer 2007-2010

Project **** Stroke and Systemic Embolism in Subjects with Non valvular Atrial Fibrillation.

Project ****superiority Study in hospitalized medically iLL patients

Project **** Study of the Safety and Efficacy of --in Subjects with Acute Coronary Syndromes

Project *** Study of the Safety and Efficacy of in Subjects with Resent ACSS

Project **** Acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2DM)
Project **** Use of a Multidrug Pill In Reducing cardiovascular Event”.

Project **** Venous thromboembolism

Project **** Acute symptomatic venous thromboembolism.

Project ****Acute decompensated heart failure

Project *** Type 2 Diabetes and Acute Coronary Syndrome

Project *** Chronic Heart Failure & reduced EF

Project *** A non intervention, cross-sectional study on primary Hypertension

Project ***Assessing the morbidity mortality benefits of patients with CAD

Project ****Drug Eluting coronary Stent System, multicenter study

Project **** Protinuria study

Project****International Registry for treatment of Heart Failure

Project****PCSK9 inhibition and cardiovascular risk reduction.

Project ***To compare long term effect ofP2Y12 on health outcomes in T2Diabetes Mellitus

ADDITIONAL SKILLS:
Address PUNE
Date of Birth : 01 Jun 1979
Gender : Male.
Marital Status Married
Languages : English, Hindi, Marathi.
Nationality : INDIAN

Dr. Amol S. Kshirsagar