Hi,
I'm Vipul Karkar

Associate Manager, CDM

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  • +91 8828229005
  • vipul@karkar.in
  • vipul.karkar.in
Education Qualifications

B.Pharm (2010)

Rajiv Gandhi University of Health Sciences, Bangalore

M.Pharm (Pharmacology) (2013)

Gujarat Technological University, Gandhinagar
Professional Experience

Cognizant Technology Solution, Mumbai

Data Analyst (Sep 2013 to Oct 2016)
Awards: 2 Unicorn, 2 Trailblazer, 2 Eureka

 

Karmic LifeSciences LLP, Ahmedabad

Sr. Clinical Data Coordinator (Oct 2016 to Feb 2018)
Awards: 1 Employee of the Quarter

 

IQVIA Biotech, Mumbai

Associate Manager, CDM (Mar 2018 to Present)
Awards: 1 Bravo, 1 Applause, 1 Bronze, 1 Shout out, 1 Innovator, 1 Pat on the back, 1 Platinum

Professional Summary

My current role puts me as a Study Lead for multiple trials of Clinical Data Management (CDM).

  • This mainly involves client facing to ascertain requirements and managing internal and external teams for efficient and quality focused delivery.
  • Proficient in applying Project management fundamentals which includes Stakeholder Management, Risk Management, Resource Management, Time Management, Scope Management, Quality Management and Communications.
  • Experienced in managing end-to-end Clinical Data Management process for Electronic Data Capture and Paper based studies.

Study Setup

Data Management Plan (DMP) Data Review Plan (DRP) Database Design/eCRF Designing and annotation with CDASH compliance Edit Check Specification/Data Validation Plan (ECS/DVP) Study Documentation Report Specs writing Data Transfer Agreements/Specifications (DTA/DTS) eCRF Completion Guidelines (eCCG), User Acceptance Testing and Unit testing (UAT/UT) Creations of Different Trackers (Productivity, Utilization) SAS Aggregate Report Specification(Productivity, Utilization)

Study Conduct

Database Management Listing Reviews Query management Reconciliations Client Communication

Study Close-out

Database Lock Checklist Clean Patient Tracker (CPT) Close out activities Creation and Managing Data Handling Log, Protocol Deviations, Note to Files
  • Experience of working on all phases of clinical trials from Phase I to Phase IV and on PMS studies including non-Interventional trials and Real-world outcome trials. Proficiency in handling Phase 2 and Phase 3 clinical trials.
  • Experienced in SAE reconciliation activities and expertise in handling third party vendor reconciliation activities including Labs, IVRS/IWRS, Endoscopy, ECG, Spirometry, ePRO, Pharmacokinetic and immunogenicity data.
  • Supportive knowledge/experience in Medical Coding (WHO-DD & MedDRA)
  • I have worked on multiple therapeutic portfolios including majorly Oncology (Solid Tumor), Cardiovascular, Respiratory and Dermatology (Psoriasis, Scabies).
  • Working knowledge of RCA, CAPA, Lean Six Sigma,
  • Highly Proficient in Microsoft Excel 2013 and above versions with ability to create macros, custom functions and automation tools for clinical studies and performing data analysis. I have also served as an Excel trainer and helped in initiating and supporting organizational sigma projects.
  • Basic understanding of Programming languages like JavaScript, SAS, Python, SQL, Visual Basic which helps me to create small applications.
  • Proficient in working on tools like, JReview, Inform Reporting Studio (Cognos), Microsoft VSS, TopTeam, FileZilla, Power BI, MS Project.