1. CURRICULUM VITAE
Abhijit Khandagale Page 1 of 7
Name: Abhijit Khandagale
Email: abhay.khandagale@gmail.com
Contact: +91-9011095512
Current Position: Currently working as a Contract Representative 2 in PRA Health sciencesPvt. Ltd, India.
EducationQualifications
Date DEGREE/CERTIFICATION INSTITUTION/UNIVERSITY
2008 Post-Graduation Diploma In Clinical
Research
Bilcare Research Academy, Pune.
2005 Bachelor of Pharmacy Satara College of Pharmacy Satara,
Kolhapur University, INDIA
2002 Diploma in Pharmacy M.S.B.T.E; Mumbai.
Cleared the ACRP Core Knowledge Assessment (CKA) examination for theCRA.
Previous Relevant Positions(s) and Experience
Employer/From – To Roles & Responsibilities
PRA Health Sciences, Mumbai
March 2016
Contracts andGrants : Pricing Assistant
1). Responsible for assisting in the tracking, finalization and analysis of fair
market value relating to clinical trials including investigator grants and
country financial exhibits.
2). Provide support to the pricing analyst/manager in the planning,
execution and control of pricing and related documents.
3). Responsible for adhoc tasks for market research.
Previous Relevant Positions(s) andExperience
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Employer/From – To Roles & Responsibilities
Sciformix Technologies India
Pvt Ltd.
April 2011-March 2016
Site contracting & site management : Contracts andGrants
Format FINAL CTA and CTA Amendments being sent to sitefor
signature.
Schedule meetings (with study team, J&J Legal, sites,etc.)
Draft multiple, Manager approved CTAAmendment(s)
Check CGA database to ensure accurate dates are inincluded
Approve drafted CTA and CTA-Amendments prior todocuments being
sent to sites by CRO.
Copied on FINAL CTA and CTA-Amendments email to site (sentby
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Previous Relevant Positions(s) andExperience
Employer/From – To Roles & Responsibilities
CRO).
Manage and track requests for GCO clinical trial insuranceinitial
certificate and update requests.
Manage the GCO insurance annual renewalprocess.
Manage and track the GCO medical expense reimbursement process
and facilitate and track the GCO legal claim process(roll- out Q4 2008)
Previous Relevant Positions(s) andExperience
Employer/From – To Roles & Responsibilities
Sciformix Technologies India
Pvt Ltd.
Site contracting & site management : Contracts andGrants
Format FINAL CTA and CTA Amendments being sent to sitefor
signature.
Schedule meetings (with study team, JNJ Legal, sites,etc.)
Draft multiple, Manager approved CTAAmendment(s)
Check CGA database to ensure accurate dates are inincluded
Approve drafted CTA and CTA-Amendments prior todocuments being
sent to sites by CRO.
Copied on FINAL CTA and CTA-Amendments email to site (sentby CRO).
Manage and track requests for GCO clinical trial insuranceinitial
certificate and update requests.
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Previous Relevant Positions(s) andExperience
Employer/From – To Roles & Responsibilities
GVK Biosciences Pvt. Ltd, India
November 2008- March 2011
Achievements
Manage the GCO insurance annual renewalprocess.
Manage and track the GCO medical expense reimbursement process
and facilitate and track the GCO legal claim process(roll- out Q4 2008)
Designation: Lead Clinical ResearchAssociate
Site contracting & site management: Handle more than 25sites.
Responsible for study related documentation.
Coordinate regulatory submissions
Ensure investigator and site compliance with the study drug protocol,
overall clinical objectives, FDA regulations, ICH Guidelines, and Good
Clinical Practice(GCP).
Conduct & coordinate Site Selection Visit.
Conduct & coordinate Study initiation Visit.
Conduct & coordinate Study Monitoring Visit.
Conduct & coordinate Site Close Out Visit.
Co-ordiante & mentor other colleagues.
1. Successfully completed 100+ Sites Monitoring visits for Registry Trial.
2. Completed patient enrolment target for 2200 patientsample Size
trial.
3. Co monitor site visits for oncology studies.
4. Co monitor site closeout visit for MDD trial.
Previous Relevant Positions(s) andExperience
Employer/From – To Roles & Responsibilities
Sanofi Pasteur India Pvt. Ltd.
Sep.2007 to Sep.2008
Designation: Scientific Promotional Executive.
To introduce & market Vaccine products (13 no’s) to the
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Previous Relevant Positions(s) andExperience
Employer/From – To Roles & Responsibilities
Achievements
Paedtrician.
Launched injectable polio vaccine for the first time in an untapped
territory.
1. Achieved sales target.
Previous Relevant Positions(s) andExperience
Employer/From – To Roles & Responsibilities
Shreya Life Sciences Pvt. Ltd.
Sep.2006 to Sep.2007
Designation: Buisness DevelopmentExecutive.
1. To sale & market of the cardiovascular, Respiratory ,
Central Nervous Systems products toKOLs.
(Key Opinion Leaders).
Employer/From – To Roles & Responsibilities
Akash Nursing Home;
Khandala.
July.2005 to Aug.2006
Designation : Hospital Pharmacist
1. To Dispense the Medications on Prescription of Doctors.
2. To make Inventory of all products.
3. To interact with patient on therapy.
4. Patient Counselling.
5. To train juniors in inventory management & prescription
dispensing.
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Experience & Expertise:
Site Feasibility Preparing Site
Agreements
Audits
Site Qualification Visits Monitoring visits & SDV Site Payments
Ethics Committee
Submissions
Site Close Out Visits Vendor (Lab, courier)
management
ICF Review Query resolution Sponsor Teleconferences
Investigators Meeting TMF maintenance
Site Initiation Visits Management of SAEs
STRENGTHS:
• Like to accept challenges goal oriented and determined.
• Believe in team work and enthusiasm in work.
• Confident to do work with best of my knowledge and efficacy.
• Quick adaptiveness.
Systems Experience/IT Skills
1. MS office (Word, Excel, Power Point and Access)
2. Completed MSCIT course
Other Relevant Details
Languages:
Speak: English, Hindi, and Marathi.
Read Write: English, Hindi, Marathi
Extracurricular activities:
1. Magazine Secretary in college gymkhana.
2. Active participation in all corporate events.
3. Singing & Playing Tennis are favourite hobbies
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Place: Pune. Yours Sincerely
Abhijit Dhansing Khandagale
Other Relevant Details
Languages:
Speak: English, Hindi, and Marathi.
Read Write: English, Hindi, Marathi
Extra-curricular activities:
4. Magazine Secretory in college gymkhana.
5. Active participation in all corporate events.
6. Singing & Playing Tennis are favourite hobbies