Kumar Krishnappa

FAQ About Kumar Krishnappa

• What is Kumar Krishnappa's address?

  Kumar Krishnappa is located at
  Worcester County, Massachusetts, United States

• What is Kumar Krishnappa's job title?

  Kumar Krishnappa is a
  PROFESSIONAL EXPERIENCE Clinical Trial Specialist (Contracted –Kelly Scientiific) Oct 2005 – Jan 2007 WYETH PHARMACEUTICALS 35 Cambridge Park Drive, Cambridge Massachusetts. • Assisted in the audit review plan for various Oncology studies carried out in US, Australia, Canada and Europe. • Performed Quality control checks on trial master file documents for regulatory compliance and generated query reports. • Coordinated with records management for data correction. • Contacted site personnel from various sites to retrieve regulatory documents in order to complete trial master file binders. • Managed trial master file binders for audit inspection by EMEA / FDA. Created tracking tools to quickly identify documents and their pathway access in the EDMS database. • Excellent exposure and experience with SOP’s, SPI’s, Clinical Database (EDMS 5.0) and employee orientation (TOPS). Clinical Operations Associate (Contracted-Aerotek) Jan 2005 – Oct 2005 PRAECIS PHARMACEUTICALS INCORPORATED 830 Winter Street, Waltham, Massachusetts. • Responsible for the collection and review of regulatory documentation, provided project management and/or data management support. • Assisted in retrieving regulatory documents from various sites for Study master file completion. • Assisted with the maintenance and archiving of Clinical Trial Master Files. • Conducted quality control audits and generated reports for Document Control. • Coordinated various aspects of the electronic document management system. EDUCATION MS, Clinical Investigation Jan 2004 MGH Institute of Health Professions, Boston, Massachusetts. BS in Pharmacy May 1998 Gautham College of Pharmacy, Bangalore University, Bangalore, India. Specialties: I have skill sets in Regulatory documents collection, tracking, reviewing and auditing. I am well versed with the ethics, rules and regulations (21 CFR 50, 54, 56, 312 and 45CFR46) governing clinical trials. I had been responsible for site qualification, initiation, review, monitor, track, and maintenance of clinical trial essential documents from the sites right from study start-up to study-closeout, maintaining the Site Master Files in the staging area for audit inspection by FDA/EMEA. Wyeth Research

• What industry does Kumar Krishnappa currently work in?

  Kumar Krishnappa currently works in the
  Wyeth Research

• What is Kumar Krishnappa's area of expertise?

  Kumar Krishnappa specializes in
  PROFESSIONAL EXPERIENCE Clinical Trial Specialist (Contracted –Kelly Scientiific) Oct 2005 – Jan 2007 WYETH PHARMACEUTICALS 35 Cambridge Park Drive, Cambridge Massachusetts. • Assisted in the audit review plan for various Oncology studies carried out in US, Australia, Canada and Europe. • Performed Quality control checks on trial master file documents for regulatory compliance and generated query reports. • Coordinated with records management for data correction. • Contacted site personnel from various sites to retrieve regulatory documents in order to complete trial master file binders. • Managed trial master file binders for audit inspection by EMEA / FDA. Created tracking tools to quickly identify documents and their pathway access in the EDMS database. • Excellent exposure and experience with SOP’s, SPI’s, Clinical Database (EDMS 5.0) and employee orientation (TOPS). Clinical Operations Associate (Contracted-Aerotek) Jan 2005 – Oct 2005 PRAECIS PHARMACEUTICALS INCORPORATED 830 Winter Street, Waltham, Massachusetts. • Responsible for the collection and review of regulatory documentation, provided project management and/or data management support. • Assisted in retrieving regulatory documents from various sites for Study master file completion. • Assisted with the maintenance and archiving of Clinical Trial Master Files. • Conducted quality control audits and generated reports for Document Control. • Coordinated various aspects of the electronic document management system. EDUCATION MS, Clinical Investigation Jan 2004 MGH Institute of Health Professions, Boston, Massachusetts. BS in Pharmacy May 1998 Gautham College of Pharmacy, Bangalore University, Bangalore, India. Specialties: I have skill sets in Regulatory documents collection, tracking, reviewing and auditing. I am well versed with the ethics, rules and regulations (21 CFR 50, 54, 56, 312 and 45CFR46) governing clinical trials. I had been responsible for site qualification, initiation, review, monitor, track, and maintenance of clinical trial essential documents from the sites right from study start-up to study-closeout, maintaining the Site Master Files in the staging area for audit inspection by FDA/EMEA.

• Which languages does Kumar Krishnappa speak? 

  Kumar Krishnappa speaks the following languages:
  No languages available.

• Which industries has Kumar Krishnappa previously worked in?   

  Kumar Krishnappa has prior experience in the following industries:
  Praecis Pharmaceuticals , Anglo French Drugs And Ind Ltd Bangalore

• What is Kumar Krishnappa’s work experience?  

  Kumar Krishnappa has the following professional experience:
  Wyeth Research , Praecis Pharmaceuticals , Anglo French Drugs And Ind Ltd Bangalore .

• How can I find Kumar Krishnappa on LinkedIn?  

  You can view Kumar Krishnappa’s
  LinkedIn profile at LinkedIn URL.

• What are Kumar Krishnappa’s work email addresses?  

  Kumar Krishnappa’s work email addresses are
  [email protected] .

• What company does Kumar Krishnappa work for?  

  Kumar Krishnappa works at
  Wyeth Research