Summary
Overview
Work History
Education
Skills
Languages
Hobbies and Interests
Personal Information
Extracurricularachievements
Clients
Declaration
Timeline
Generic
SAIPRASAD KUNDER

SAIPRASAD KUNDER

Mumbai

Summary

Intend to be a part of an organisation which offers scope to enhance my knowledge and skills in profession and at the same time I will deliver my best to the organization . Wish to work with people having common goal of achieving technological blend and grow as a human being.

Overview

7
7
years of professional experience

Work History

Senior Process Associate (Clinical Study Associate)

TATA Consultancy Services
12.2020 - Current
  • Responsible for providing operational support to multiple global study management teams (SMTs) through all phases of clinical study management (Plan, Start-up, Conduct, and Close-out) in accordance with the appropriate quality standards including ICH/GCP and applicable regulations
  • Responsible for reviewing and maintaining accurate study level progress information and efficient use of systems, tools and reports
  • Contributes to the development, set up and maintenance of study specific tools
  • Reviews standard study related reports and liaises with accountable study members to address any inconsistencies and missing information, as appropriate
  • Ensures any data compliance or quality issues are escalated through the correct pathway
  • Provides the SMT with guidance and know how to support the effective use of system functionality
  • Coordinates activities to ensure CRO and vendor delivery against the contracted scope of work
  • Responsible for communication between the study team and vendor for defined tasks and tracking information – troubleshoot issues ensuring vendor and CROs are working according to the contracted Scope of Work, Escalate to the study team as appropriate
  • Ensure essential study information is tracked
  • Act as a liaison with CRO and vendors during study, for defined tasks, to ensure effective conduct of the study under the direction of Clinical Operations Lead (COL)
  • Develop, maintain and manage appropriate study documentation
  • Manages study touchpoint area according to the global standards, including set up, access, rights and maintenance of the study related documents
  • Maintains Trial Master File (TMF) for the study(s), in accordance with SOP requirements under the direction of COL
  • Participates in the development and distribution of the newsletters for investigators and monitors as needed
  • Organises the agenda and the minutes, taking rotation list for the SMTs and operations team meetings as needed
  • Track and maintain study information and report on study progress
  • Provides guidance to the SMT on the availability of SMT/operational/data management tracking systems, templates and tools and sets up all tracking systems/tools in consultation with the Sr
  • COL, COL and SDM
  • Provides the Sr
  • COL, COL, SDM and Global Bio Sample Specialist with regular updates on status and metrics using standard/automated reports and other applications
  • Communicates and follows-up on any discrepancies within the study under the direction of the Sr
  • COL and COL
  • Provide input into the development of best practices and advises on the availability of standardized tracking tools and templates
  • Proactively incorporates learning and recommendations from other study debriefs and best practices
  • Contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function
  • Ensures GCP regulations and SOPs are adhered to within the SMT(s)
  • Maintains oversight and ensures consistency across studies within a project
  • Attends and provides input to study level debrief meetings
  • Tools/Portals – CTMS, eTMF, RAVE, SIP, CIDM, Veeva Vault/Clinical Vault, Spotfire, Dolphin metrics, Almac, Calyx, Signant Health

Quality Expert

IKS Health
10.2019 - 12.2020
  • Managing US physician's documentation on the electronic platform
  • Auditing a summarized chart note and noting down errors
  • Finding out the root cause of the error, providing effective feedback to the employees and trying to improve the performance of employees
  • Noting down the changes made by the physician in an old chart note and finding out preferences of the physician
  • Conducting feedback sessions for employees

Clinical Associate

IKS Health
10.2017 - 10.2019
  • Managing US physician's documentation on the electronic platform
  • Summarizing the physician patient interaction under different fields like history of present illness, review of systems, physical examination, and plan details
  • Populating the summarized data in the Electronic Health Record (EHR) and generating the chart note

Education

M.Sc - Biotechnology

University of Mumbai
01.2017

B.Sc. - Biotechnology

National College
01.2015

HSC -

National College
01.2012

SSC -

Cardinal Gracias High School
01.2010

Skills

  • Typing
  • MS Word
  • MS Excel
  • MS PowerPoint

Languages

  • Hindi
  • English
  • Marathi
  • Tulu

Hobbies and Interests

  • Sports
  • Photography
  • Reading

Personal Information

  • Date of Birth: 12/19/94
  • Marital Status: Unmarried

Extracurricularachievements

  • Vice-President, YuvaRajaka in Shree RajakaSangha Trust, 2016-2018, Handled a team of 150 youths., Organized events on a huge scale covering every activity ranging from sports, cultural events, educational seminars, health drives and community service.
  • Volunteer, ResQink Association of Wildlife Welfare (RAWW)

Clients

  • Roche
  • Iowa Clinic
  • LVHN Clinic

Declaration

  • I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.

Timeline

Senior Process Associate (Clinical Study Associate)

TATA Consultancy Services
12.2020 - Current

Quality Expert

IKS Health
10.2019 - 12.2020

Clinical Associate

IKS Health
10.2017 - 10.2019

M.Sc - Biotechnology

University of Mumbai

B.Sc. - Biotechnology

National College

HSC -

National College

SSC -

Cardinal Gracias High School
SAIPRASAD KUNDER