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