H. Kumar
Bangalore
Summary
Seeking for a position to work in a challenging environment that offers plenty of opportunities for me to develop my career with in the company and to be the part of innovation and development.
Overview
15
15
years of professional experience
Work History
Record Management Specialist-III (e-TMF)
ICON Strategic Solutions Pvt. Ltd
12.2018 - Current
- Uploading documents and initiating workflow in Sponsor eTMF
- Performing Quality checks for e-documents and paper documents
- Performing analysis activity with regard to the Timelines, Completeness and Quality of eTMF
- Follow processes for set up, maintenance, and support for assigned TMF projects
- Serve as TMF contact for documentation to Project team; cross-functional departments to ensure high quality TMF deliverables are met on time
- Assist CTL and Clinical Analyst with accurately updating and maintaining clinical systems (CTMS) to track site compliance and performance within project timelines
- Assist DOCS Manager and Team Lead with eTMF review activities such as updating, communication with CRAs, EDM, EVOC teams for audit preparation and other activities as assigned
- Veeva Vault, Spectrum, and Request Tool
- Country/Site/Study/Product level document collection from Site/CRA/CTA/RSU & Document & email upload
- Work allocation and tracking the completeness on daily basis
- Mentoring and acting as a SME
- Performing Monthly QC and getting CAPA for the errors, conducting retraining to avoid reoccurance
Clinical Research Associate Study Manager
Micro Therapeutic Research Labs Private Ltd
02.2016 - 04.2018
- Overall responsibility for Study Management, Performing and monitoring the clinical studies accordance to protocol
- Responsible for ensuring the preparation of study related documents (study synopsis, clinical study updates) with in stipulated time and as per the applicable regulatory requirements
- Communicate with individual departments and collect the documents
- Ensure to get the training to all study individual personnel will train from the principal investigator or Clinical investigator
- Ensure the study personal should follow as per protocol
- Ensure to follow SOPs for handling of investigational product, administration, documentation, storage conditions and retention
- Ensure the subject safety and maintain the records according the regulatory requirements
- Recording adverse event and serious adverse event and safety follow-up for the subject
- Co-ordinate with all the departments regarding full fill the TMF documents
- Ensure the find out the documentation errors, full fill the missing documents (with time line period), and final close outs
- Ensure the sponsor requirement documents for TMF
- Communicate IEC regarding the study updates
- Maintenance the records as TMF adverse event follow up records
QC Executive
Ratna Bioteck
07.2009 - 08.2011
- Herbal extraction
- R&D
Education
M.sc. - Genetics& Genomics
Yogivemana University
Kadapa05.2013
Degree - Biotechnology
Mother Teresa Degree College
Palamaner05.2009
Intermediate - Biological Sciences
Madhuvidhyanikethan Jr.college
Palamaner 03.2006
SSC -
ZPHS,GLS.farm
01.2003
Skills
- MS Office
Accomplishments
Participated in National level conference on Emerging Trends in GENOMICS
Operatingsystems
- Windows 7
- Windows 10
- Windows 11
- Windows XP
- Windows Home Basic
Personal Information
- Date of Birth: 07/10/88
- Nationality: Indian
Areas Of Interest
- Clinical Research
- Team management
Extracurricular Activities
Blood Donation Sports Hunting
Hobbies and Interests
- Listening songs
- Playing cricket
- Cooking
- Hunting
Disclaimer
I hereby assure you that the information furnished above is true to the best of my knowledge.
Timeline
Record Management Specialist-III (e-TMF)
ICON Strategic Solutions Pvt. Ltd
12.2018 - Current
Clinical Research Associate Study Manager
Micro Therapeutic Research Labs Private Ltd
02.2016 - 04.2018
QC Executive
Ratna Bioteck
07.2009 - 08.2011
M.sc. - Genetics& Genomics
Yogivemana University
Degree - Biotechnology
Mother Teresa Degree College
Intermediate - Biological Sciences
Madhuvidhyanikethan Jr.college
SSC -
ZPHS,GLS.farm
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