Passionate about exploring the beauty of mountains and jungles, I found solace and inspiration in nature"s embrace
Yogita Singh
Team Leader, Clinical Research
Noida,Uttar Pradesh
Summary
Versatile clinical research professional knowledgeable about Regulatory submission with extensive knowledge of Global regulations and guidelines in clinical research. Proficient in coordinating and preparing regulatory submissions, including INDs, CTAs, NDAs, BLAs and MAAs. Skilled in managing timelines and budgets, conducting risk assessments, and leading cross-functional teams. Proficient in interpreting complex clinical data to create compelling and engaging educational materials. Skilled in collaborating with medical professionals / agencies/CROs and meeting tight deadlines.
Overview
29
29
years of professional experience
Work History
Team Leader Clinical Research
Fortis Memorial Research Institute
03.2021 - Current
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Followed clinical research protocols and conducted study visits in compliance with
- ICH/GCP and FDA regulations
- Maintained compliance with protocols covering patient care and clinical trial operations
- Monitored patient safety throughout clinical trials and reported any adverse events
- Well versed/ informed with SAE reporting and SUGAM portal functions
- Assisted with day-to-day operations, working efficiently and productively with all team members.
Senior Research Coordinator
Medanta, The Medicity
, Gurugram
07.2017 - 03.2021
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research related protocols
- Maintained compliance with protocols covering patient care, follow up and clinical trial operations
- Monitored patient safety throughout clinical trials and reported any adverse events
- Assisted with day-to-day operations, working efficiently and productively with all team members.
Assistant Professor
Uday Pratap Autonomous Degree College
Varanasi
08.2008 - 06.2017
- Revised course objectives, course materials, and instructional and assessment strategies for Life Science courses
- Collaborated with faculty members on projects
- Proctored exams and provided remediation for learning improvement goals
- Handled classroom administration for professors
- Applied innovative teaching methods to encourage student learning objectives
- Communicated with students about the classroom, lab and study session expectations to help professors maintain order in large classes.
Assistant Professor
St Joseph's
Gorakhpur
03.2006 - 08.2007
- Established a completely new department for graduate students in Life Sciences including Lab facilities.
Scientist
Indian Herbs
Saharanpur
11.1998 - 04.2001
- As a Scientist C in a herbal company focused on drug testing, I have excelled in leading and executing impactful research projects
- My expertise lies in designing and conducting experiments to evaluate the efficacy and safety of herbal formulations for drug development purposes
- Effectively analysing and interpreting data, I have contributed to the successful identification and validation of novel herbal compounds with potential therapeutic applications
- With a strong commitment to quality and compliance, I adhere to rigorous regulatory guidelines while maintaining accurate documentation and contributing to scientific publications and presentations.
Senior Research Fellow
Council of Scientific and Industrial Research
New Delhi
04.1997 - 11.1998
Project Research Fellow
Dabur India private Limited
06.1996 - 04.1997
Project Research fellow
Roussel Scientific Institute
08.1994 - 06.1996
- During my core research experience, I have obtained and successfully completed various prestigious fellowships
- These opportunities have allowed me to immerse myself in cutting-edge research projects, collaborate with renowned experts, and contribute significantly to the advancement of knowledge in my field
- With a strong focus on innovation
- I have tackled complex scientific challenges, applying diverse methodologies and techniques to generate meaningful results
- Through these fellowships, I have developed expertise in critical analysis, data interpretation, and effective communication of research findings
- The recognition and support garnered from these fellowships further reinforce my commitment to excellence in scientific research and drive to make significant contributions to the field.
Education
PG Diploma - Advance Clinical Research and Pharmacovigilance
ICRI New Delhi
PhD - undefined
Jadavpur University
Master of Science (M. Sc - undefined
Banaras Hindu University
Accomplishments
- Acted as a resource person in Hands on training workshop in 2016-2019 in DBT Program
- Acted as a resource person in various training workshops organized in college time to time
- One month training of SAS software
- Attended a workshop on Basic Excel
- Published various abstracts in different reputed, indexed journals
- Participated in various webinars related to amendments in clinical research (during Covid time), management of Covid -19 and other topics from march 2021to till date
- Managed and worked more than 90 trials (Academic and Sponsored) as
- Team lead clinical Research, FMRI, Gurugram
- Completed successful audits (with no or very minimal compliances) of
- FDA, JCI, NABH, DCGI and DHR
- Organized CMEs, webinars, workshops and conferences time to time
- Certificates
- Completed Certificate course in drug regulatory affairs (DRA)
- Completed Course “Executive Diploma in Healthcare Management”
- Completed Internationally accredited certificate in nutrition
- Completed Internationally accredited certificate in Gut Health
- Completed writing with confidence: writing Beginner to Writing Pro
- Completed current regulatory requirements for conducting clinical trials in India for Investigational New Drugs
- Project Management skills for leaders
- Team Work Essentials: Stand out as a valuable team member
- Membership:
- International brain research organization (IBRO)
Certification
Leadership and Teamwork
Good Clinical Practice (GCP)
Effective Time Management
Project Management
Clinical Monitoring
Clinical Trial Management System (CTMS)
Serious Adverse Event (SAE) Reporting
Electronic Data Capture (EDC)
IRB and Regulatory Submissions
Federal & State Regulations
Electronic Common Technical Document (eCTD)
Regulatory document Management
Document review and Management
Corrective and Preventive Action (CAPA)
Policy Analysis
Medical writing
Clinical Trial Operations
Affiliations
Indian Academy of Neuroscience (IAN)
Indian Science Congress Association (ISCA)
Member of Editorial Board - The International Journal of Novel
research and Development
Interests
Additionally my artistic inclinations drive me to immerse myself in painting and sketching capturing the essence of captivating landscapes
Equally, I indulge in the captivating world of Novels, where each book becomes a gateway to adventure and knowledge
Skills
- Clinical Research
- Leadership and Teamwork
- Effective Time Management
- Good Clinical Practice (GCP)
- Medical Writing
- Clinical Monitoring
- Clinical Trial Management System (CTMS)
- Serious Adverse Event (SAE) Reporting
- Electronic Data Capture (EDC)
- IRB and Regulatory Submissions
- Federal & State Regulations
- Electronic Common Technical Document (eCTD)
- Project management
- Document Management and submission
- Corrective and Preventive Action (CAPA)
- Document Review and submission
- Policy Analysis
- Subject Matter Expert
Timeline
Team Leader Clinical Research
Fortis Memorial Research Institute
03.2021 - Current
Senior Research Coordinator
Medanta, The Medicity
07.2017 - 03.2021
Assistant Professor
Uday Pratap Autonomous Degree College
08.2008 - 06.2017
Assistant Professor
St Joseph's
03.2006 - 08.2007
Scientist
Indian Herbs
11.1998 - 04.2001
Senior Research Fellow
Council of Scientific and Industrial Research
04.1997 - 11.1998
Project Research Fellow
Dabur India private Limited
06.1996 - 04.1997
Project Research fellow
Roussel Scientific Institute
08.1994 - 06.1996
PG Diploma - Advance Clinical Research and Pharmacovigilance
ICRI New Delhi
PhD - undefined
Jadavpur University
Master of Science (M. Sc - undefined
Banaras Hindu University
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