Shweta Kahar
Pune
Summary
Versatile, dedicated and strategic clinical research professional with expertise in managing clinical trials, leading teams, and ensuring regulatory compliance. Adept at building strong relationships with stakeholders and driving studies to successful completion. Committed to delivering high-quality results and advancing healthcare innovation. Regulatory affair manager- medical devices, developed and reviewed clinical study protocols and related documents for medical device. Assistant Professor with a strong passion for teaching and research mentorship of research assistants and more than 150 students.
Overview
11
11
years of professional experience
1
1
Certification
Work History
CLINICAL RESEARCH MANAGER
Indian Institute of Clinical Research Management
Pune
2022.07 - Current
- Developed and managed research projects, resulting in 86 research project
- Designed and implemented curriculum for Post Graduate Diploma Course in Clinical Research Technology and Post Graduate Diploma in Clinical Data management and Pharmacovigilance at Savitribai Phule Pune University
CLINICAL RESEARCH MANAGER
VIRTUAL SENSE GLOBAL TECHNOLOGIES PVT LTD
2021.10 - 2022.05
- Managed FDA documentation and compliance for Class I medical devices
- Ensured regulatory compliance with ISO 13458/10993/18562 (International Organization for Standardization), Conformité Européenne (CE) certification, Institute for Printed Circuits (IPC) PCB-related standards
- Indian and international Regulatory standards to launch medical device in India and abroad
- Collaborated with internal teams for pilot clinical trial and risk management for internal testing of medical device and developed other study related documents
- Moderated Application development of medical device and Electronic medical/health records
CLINICAL RESEARCH MANAGER
CHELARAM DIABETES INSTITUTE
Pune
2015.12 - 2021.03
- Type 2 Diabetes Mellitus (Injectable) Phase III Jan 2021 - Mar 2021
- Type 2 Diabetes Mellitus (Oral) Phase III Jan 2021 Mar 2021
- Investigator Initiated Trial - Jan 2021 - Mar 2021 Time in Range - In
- MODY Academic Study Jan 2021 Mar 2021
- Type 2 Diabetes Mellitus (Injectable) Real World Observational Study - Aug 2020 Mar 2021
- Type 2 Diabetes Mellitus (Questionnaire Based) - Real World Observational Study Jan 2020 Mar 2021
- Cardiovascular Outcomes Phase III Dec 2019 Mar 2021
- Type 2 Diabetes Mellitus (Oral) Phase III Aug 2019 Mar 2021
- Diabetic Foot Ulcer Phase III Dec 2018 - Mar 2021
- Type 2 Diabetes Mellitus - International Real World Observational Study Oct 2018 Sept 2020
- Atherosclerosis - Academic Study Jun 2018 Mar 2021
- Obesity Phase III Apr 2018 - Dec 2020
- Type 2 Diabetes Mellitus with Dyslipidemia Investigator Initiated Trial Jan 2018 Mar 2021
- Type 2 Diabetes Mellitus - Phase IV Jan 2018 - Mar 2021
- Type 2 Diabetes Mellitus International Academic Research Project - Aug 2017 Mar 2021
- Type 2 Diabetes Mellitus - Rural Indian Community Based Academic Research Study Dec 2015- Jun 2017.
INSTITUTIONAL REGULATORY BOARD COORDINATOR
CHELARAM DIABETES INSTITUTE
Pune
2015.12 - 2018.02
- Audited Finances of Ethics Committee
- Site Audits and Review of Ongoing Projects during site monitoring/audit
- Handled Communications with DCGI or Licensing Authority
- Organized Ethics Committee Meetings
- Prepared and archived record of all regulatory approval letters (Sponsor protocol, PG thesis & ICMR projects)
- Developed & maintained systems to track study progress, documentation, contact sheets, regulatory documents & annual study status reports
- Checked study feasibility
- Handled archiving of clinical trial documents
- Handled communications with site, CRO, SMO or sponsor regarding AE/SAEs or any study related issues
- Handled timely completion of regulatory project & submission of documentation.
CLINICAL RESEARCH COORDINATOR
GETWELL HOSPITAL AND RESEARCH CENTER
Nagpur
2013.04 - 2014.04
- Type 2 Diabetes Mellitus Phase III
Education
POST GRADUATION DIPLOMA IN CLINICAL RESEARCH & MANAGEMENT -
INDIAN INSTITUTE OF CLINICAL RESEARCH & MANAGEMENT
NAGPURBSC IN BIOTECHNOLOGY -
G. H. RAISONI INSTITUTE OF INTERDISCIPLINARY SCIENCES - NAGPUR
NAGPURHSC -
SANDIPANI JR COLLEGE NAGPUR
NAGPUR01.2009
SSC (CBSE) -
BHARTIYA KRISHNA VIDYA VIHAR - NAGPUR
NAGPUR01.2007
MSC IN DIETETICS & FOOD SERVICE MANAGEMENT -
INDIRA GANDHI NATIONAL OPEN UNIVERSITY NAGPUR
NAGPUR01.2013
Skills
- Regulatory strategy and planning
- Regulatory knowledge and compliance (GCP, FDA, IRB, ICH)
- Experience with medical device classification, labeling, and submissions
- Understanding of medical device design, development, and testing processes
- Familiarity with quality systems regulation (QSR) compliance and risk management of medical device
- Preparation and implementation of regulatory submissions, technical files, and design dossiers
- Project management skills, including timelines, budgets, and resource allocation
- Conducting internal audits and gap analyses
- Providing regulatory training and guidance to colleagues and stakeholders
- Staying up-to-date with changing regulations and industry best practices
- Curriculum development and implementation: Lecture preparation, Course evaluation, assessment, and delivery
- Course lead Mentoring of faculty, supervision of research assistants and students
- Public speaking, presentation, collaborative teamwork, and leadership
- Interpersonal and cross-cultural communication
- Experience with Oracle Clinical 5.4.0 and Oracle Argus 8.2.3 software
- Clinical trial management (Phase I-IV)
- Study protocol development and implementation, Case report form (CRF) design and management
- Project planning, Site management, and monitoring
- Strong organizational and time management skills- Built and maintained high-performing teams through effective recruitment, training, and Resource allocation
- Investigational product management (IPM)
- Serious Adverse event (SAE) and Adverse event (AE) reporting and management
- Timeline management and milestones
- Budgeting, financial management, and negotiation
- Risk management, Conflict resolution, and problem-solving
- Stakeholder management (sponsors, investigators, regulatory authorities)
- Electronic data capture (EDC) systems, Clinical trial management systems (CTMS) and Electronic trial master file (eTMF) systems
- Microsoft Office (Excel, Word, PowerPoint)
- Attention to detail and quality focus
- Flexibility and adaptability
- Preparing SOP, Identification & reporting of AE/SAE within the timeline to stakeholders & patient follow up
- Coordinated and executed more than 35 successful events, including G20 Pune India, conferences, seminars, and workshops
Paperspublications
- Glycation of glucose sensitive lysine residues K36, K438 and K549 of albumin is associated with prediabetes International Journal of Proteomics 2019 Rajeshwari Rathore, Babasaheb P. Sonwanea, M.G. A.G. Unnikrishnan, Mahesh J. Kulkarnia Jagadeeshaprasada, Shweta Kahar, B. Santhakumaria
- Providing Advance Diabetes Screening in Rural India: Results from the Chellaram Diabetes Institute's 2nd Mobile Diabetes Programme 2018 DD Pratyush, P B Dhore, SR Kahar, MK Mandal, A G Unnikrishnan
Certification
- Good Clinical Practice training completed on 12th July 2024 with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN27201201000024C.
- Kalpavriksha Investors’ Summit and Demo Day on 06 April 2024 as Organizing Committee. Organized by Department of Science & Technology (DST), The Startup Funding Practice, Pune Management Association, CFO Club and DST-TEC Department of Technology SPPU.
- TEC (Technology Enabling Centers) Conclave 2024 on 14th March 2024 at DEL-NET Jawaharlal Nehru University Delhi organized by GOVERNMENT OF INDIA, MINISTRY OF SCIENCE & TECHNOLOGY, DEPARTMENT OF SCIENCE & TECHNOLOGY, Technology Translation and Innovation (TTI) Division. Department of Science & Technology (DST) Technology Enabling Centers (TEC)
- AI-Powered Femtech- Transforming Women’s Lives Globally On 7th March 2024 as Organizing Committee. Organized by Department of Technology SPPU, Transvitals Pvt Ltd, and Sahyadri Hospital Transvitals Pvt Ltd has launched India’s first hi fidelity Fertility Tracking device and app OvuPro.
- Meri Maati Mera Desh “Selfie with Soil” Guinness book world record 2023 - face of the campaign and Data Collection Team Lead. meeting attended at University of Mumbai on 9th Nov 2023.
- G20 Pune- 4th Educational Working Group Meeting 17th June to 23rd June 2023 organized by Savitribai Phule Pune University as an Organizing Committee member and International Liaison officer.
- 5th International Diabetes Summit 9-11 Mar 2021 Organized by Chellaram Diabetes Institute Delegate and Organizer GCPE6 (R2), ICMR guidelines 2017, ICMR Guidelines during Covid Pandemic 2020, New Drug Clinical Trial Rules 6 Jan 2021- Organized by Harrison's Training Academy.
- 4th International Diabetes Summit 6-8 Mar 2020 Organized by Chellaram Diabetes Institute Delegate and Organizer
- ICH GCP, and Clinical Trial Regulations 17 Sept-Apr 2019- Harrison Tech Consultant.
- 3rd International Diabetes Summit 8-10 Mar 2019 - Organized by Chellaram Diabetes Institute Delegate and Organizer
- Retention Meeting Milan, Italy 23 Nov 2018 - Organized byNovo Nordisk
- Investigator Meeting Athens, Greece 25-26 Apr 2018 - Organized by Novo Nordisk
- GCP, Schedule Y Training And NABH Accreditation Standards for Ethics Committee organized 03 Apr 2018 Harrison Tech Consultant.
- 2nd International Diabetes Summit-9-11 Mar 2018 - Organized by Chellaram Diabetes Institute Delegate and Organizer
- International Diabetes Summit 10-12 Mar 2017- Organized by Chellaram Diabetes Institute Delegate and Organizer
- Advance Course in Diabetes Care for Nursing Specialities (ACDCNS)-14-15 Nov 2016- Organized by Chellaram Diabetes Institute Organizer
- Diabetes Awareness and Protocol Training of Project Diabetes with Dignity 28 Jul-1 Aug 2016 Organized by Chellaram Diabetes Institute on Delegate and Organizer
- CME Diabetes Masterclass-6-7 Aug 2016 - Organized by Chellaram Diabetes Institute on - Delegate
- Advance Management of Diabetes 21 Feb 2016 Organized by Chellaram Diabetes Institute on - Delegate
- Madhumeh 2015 World Diabetes Day 22 Nov 2015 Organized by Chellaram Diabetes Institute on Delegate Good Clinical Practice & Recent Updates in Clinical Trial 22 Mar 2015 Organized by Care Hospital Nagpur Delegate and Organizer Dietetics and food service management (Internship)- Jul Oct 2015 Poona Hospital & research center, pune Basic biostatistics in Medical Research 21 Feb 2015 Organized by Government Medical College, Nagpur - Delegate and Organizer
- Updates in Regulatory Guidelines in Clinical Trial 16 Jan 2015- Organized by Quintiles, Mumbai Delegate and Organizer Nutritional and Health Checkup Camp 21 nov 2014 Organized by Sadabai Raisoni Women's College Delegate and Organizer
- Madhumeh 2014 - World Diabetes Day 9 Nov 2014- Organized by Chellaram Diabetes Institute on Delegate
- Scientific Writing in Biomedical Research 22 Sept 2014 - Organized by Government Medical College, Nagpur Delegate and Organizer
- 2nd Annual National Conference 23-24 Nov 2013 Organized by Association of Diabetes Educators, Nagpur Member & Attendee.
- International conference on harmonization- good clinical practice & schedule Y June 2013 Organised by Indian Institute of Clinical Research & Management, Nagpur.
- Certificate Course in Food and Nutrition Dec 2013 Indira Gandhi National Open University
- Won Bronze Medal at National Level 2005- Organised by World Funakosi Sotokan Karate Organization
- Won Gold Medal at District Level - 2005 - Organised by World Funakosi Sotokan Karate Organization
- Won Bronze Medal at National Level-2004- Organised by World Funakosi Sotokan Karate Organization
- Won Gold Medal at District Level - 2004- Organised by World Funakosi Sotokan Karate Organization
- Awarded "National Association for Disabled" Certification 2003 Organized by Shanti Bhavan, Nagpur
Affiliations
- Dr Harshdeep Kamble Additional Secretary Industries, Energy and labour department, Mantralay Mumbai Maharashtra on 29th April 2024
Accomplishments
- Awarded Outstanding Faculty and Research in September 2022
Timeline
CLINICAL RESEARCH MANAGER
Indian Institute of Clinical Research Management
2022.07 - Current
CLINICAL RESEARCH MANAGER
VIRTUAL SENSE GLOBAL TECHNOLOGIES PVT LTD
2021.10 - 2022.05
CLINICAL RESEARCH MANAGER
CHELARAM DIABETES INSTITUTE
2015.12 - 2021.03
INSTITUTIONAL REGULATORY BOARD COORDINATOR
CHELARAM DIABETES INSTITUTE
2015.12 - 2018.02
CLINICAL RESEARCH COORDINATOR
GETWELL HOSPITAL AND RESEARCH CENTER
2013.04 - 2014.04
POST GRADUATION DIPLOMA IN CLINICAL RESEARCH & MANAGEMENT -
INDIAN INSTITUTE OF CLINICAL RESEARCH & MANAGEMENT
BSC IN BIOTECHNOLOGY -
G. H. RAISONI INSTITUTE OF INTERDISCIPLINARY SCIENCES - NAGPUR
HSC -
SANDIPANI JR COLLEGE NAGPUR
SSC (CBSE) -
BHARTIYA KRISHNA VIDYA VIHAR - NAGPUR
MSC IN DIETETICS & FOOD SERVICE MANAGEMENT -
INDIRA GANDHI NATIONAL OPEN UNIVERSITY NAGPUR
- Good Clinical Practice training completed on 12th July 2024 with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN27201201000024C.
- Kalpavriksha Investors’ Summit and Demo Day on 06 April 2024 as Organizing Committee. Organized by Department of Science & Technology (DST), The Startup Funding Practice, Pune Management Association, CFO Club and DST-TEC Department of Technology SPPU.
- TEC (Technology Enabling Centers) Conclave 2024 on 14th March 2024 at DEL-NET Jawaharlal Nehru University Delhi organized by GOVERNMENT OF INDIA, MINISTRY OF SCIENCE & TECHNOLOGY, DEPARTMENT OF SCIENCE & TECHNOLOGY, Technology Translation and Innovation (TTI) Division. Department of Science & Technology (DST) Technology Enabling Centers (TEC)
- AI-Powered Femtech- Transforming Women’s Lives Globally On 7th March 2024 as Organizing Committee. Organized by Department of Technology SPPU, Transvitals Pvt Ltd, and Sahyadri Hospital Transvitals Pvt Ltd has launched India’s first hi fidelity Fertility Tracking device and app OvuPro.
- Meri Maati Mera Desh “Selfie with Soil” Guinness book world record 2023 - face of the campaign and Data Collection Team Lead. meeting attended at University of Mumbai on 9th Nov 2023.
- G20 Pune- 4th Educational Working Group Meeting 17th June to 23rd June 2023 organized by Savitribai Phule Pune University as an Organizing Committee member and International Liaison officer.
- 5th International Diabetes Summit 9-11 Mar 2021 Organized by Chellaram Diabetes Institute Delegate and Organizer GCPE6 (R2), ICMR guidelines 2017, ICMR Guidelines during Covid Pandemic 2020, New Drug Clinical Trial Rules 6 Jan 2021- Organized by Harrison's Training Academy.
- 4th International Diabetes Summit 6-8 Mar 2020 Organized by Chellaram Diabetes Institute Delegate and Organizer
- ICH GCP, and Clinical Trial Regulations 17 Sept-Apr 2019- Harrison Tech Consultant.
- 3rd International Diabetes Summit 8-10 Mar 2019 - Organized by Chellaram Diabetes Institute Delegate and Organizer
- Retention Meeting Milan, Italy 23 Nov 2018 - Organized byNovo Nordisk
- Investigator Meeting Athens, Greece 25-26 Apr 2018 - Organized by Novo Nordisk
- GCP, Schedule Y Training And NABH Accreditation Standards for Ethics Committee organized 03 Apr 2018 Harrison Tech Consultant.
- 2nd International Diabetes Summit-9-11 Mar 2018 - Organized by Chellaram Diabetes Institute Delegate and Organizer
- International Diabetes Summit 10-12 Mar 2017- Organized by Chellaram Diabetes Institute Delegate and Organizer
- Advance Course in Diabetes Care for Nursing Specialities (ACDCNS)-14-15 Nov 2016- Organized by Chellaram Diabetes Institute Organizer
- Diabetes Awareness and Protocol Training of Project Diabetes with Dignity 28 Jul-1 Aug 2016 Organized by Chellaram Diabetes Institute on Delegate and Organizer
- CME Diabetes Masterclass-6-7 Aug 2016 - Organized by Chellaram Diabetes Institute on - Delegate
- Advance Management of Diabetes 21 Feb 2016 Organized by Chellaram Diabetes Institute on - Delegate
- Madhumeh 2015 World Diabetes Day 22 Nov 2015 Organized by Chellaram Diabetes Institute on Delegate Good Clinical Practice & Recent Updates in Clinical Trial 22 Mar 2015 Organized by Care Hospital Nagpur Delegate and Organizer Dietetics and food service management (Internship)- Jul Oct 2015 Poona Hospital & research center, pune Basic biostatistics in Medical Research 21 Feb 2015 Organized by Government Medical College, Nagpur - Delegate and Organizer
- Updates in Regulatory Guidelines in Clinical Trial 16 Jan 2015- Organized by Quintiles, Mumbai Delegate and Organizer Nutritional and Health Checkup Camp 21 nov 2014 Organized by Sadabai Raisoni Women's College Delegate and Organizer
- Madhumeh 2014 - World Diabetes Day 9 Nov 2014- Organized by Chellaram Diabetes Institute on Delegate
- Scientific Writing in Biomedical Research 22 Sept 2014 - Organized by Government Medical College, Nagpur Delegate and Organizer
- 2nd Annual National Conference 23-24 Nov 2013 Organized by Association of Diabetes Educators, Nagpur Member & Attendee.
- International conference on harmonization- good clinical practice & schedule Y June 2013 Organised by Indian Institute of Clinical Research & Management, Nagpur.
- Certificate Course in Food and Nutrition Dec 2013 Indira Gandhi National Open University
- Won Bronze Medal at National Level 2005- Organised by World Funakosi Sotokan Karate Organization
- Won Gold Medal at District Level - 2005 - Organised by World Funakosi Sotokan Karate Organization
- Won Bronze Medal at National Level-2004- Organised by World Funakosi Sotokan Karate Organization
- Won Gold Medal at District Level - 2004- Organised by World Funakosi Sotokan Karate Organization
- Awarded "National Association for Disabled" Certification 2003 Organized by Shanti Bhavan, Nagpur
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