Suresh Kumar
Ahmedabad
Summary
Highly motivated Master of Pharmacy Student with a strong passion for clinical data management. Possess a solid foundation in pharmaceuticals and a keen understanding of data management techniques. Seeking to leverage my academic background, analytical skills, and attention to detail to contribute effectively to the clinical research field. Eager to apply my knowledge in a dynamic team environment to ensure accurate and efficient data management and analysis for improved healthcare outcomes.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Clinical Data Associate
Bioscan Research
Ahmedabad
02.2024 - Current
- Engage with study subjects to meticulously gather, document, categorize, and maintain clinical data pertinent to the study
- Foster consistent communication with physicians to guarantee subjects undergo scheduled scans during their visits, ensuring data integrity and study adherence
- Address inquiries from study subjects regarding the study, offering clarity and guidance where necessary to maintain participant engagement and compliance
- Execute additional tasks as necessary, including conducting client demonstrations, to support the smooth progression of clinical operations and foster positive relationships with stakeholders.
Executive Corporate Affairs
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad
12.2022 - 02.2024
- Prepared and submitted technical documents for regulatory approvals to authorities such as CDSCO, FDA, CBN and Prohibition & Excise
- Evaluated document accuracy and provided enhancement suggestions
- Liaised with regulatory authorities and ensured compliance
- Collaborated cross-functionally to gather required information
- Stayed updated on regulatory changes and industry trends
- Implemented quality assurance measures for document integrity
- Proactively addressed regulatory queries and requests.
Education
Master of Pharmacy (Pharmaceutical Chemistry) -
Central University of Rajasthan
Ajmer07-2022
Bachelor of Pharmacy -
Madhav University
Sirohi05-2020
HSC -
GSSS
Koselao04-2016
SSC -
GSSS
Pawa04-2014
Skills
- Good knowledge of clinical trial phases and clinical terminology
- Understanding of clinical trial data processes and industry regulations (ICH-GCP, 21 CFR Part 11)
- Dedicated to maintaining patient confidentiality and adhering to ethical guidelines
- Proven track record in ensuring regulatory compliance
- Basic knowledge about clinical data management software, such as Medidata Rave and Oracle Inform
- Analytical skills
- Easy adopt new environments
- Quick learner
- Ability to do work individually or team
- Self-motivated & high patience
- Handle difficult situations
- Strong communication & problem solving skills
Certification
- Certificate Course in Clinical Research & Pharmacovigilance, Quiscon Biotech, 590165
- Clinical Data Management: A Data Driven Path to Effective Healthcare, AptSkill, APT4303340
Accomplishments
- GPAT (Graduate Pharmacy Aptitude Test) (2020)
- NIPER (National Institute of Pharmaceutical Education & Research) (2020)
- CUCET (Central University Common Entrance Test) (2020)
Disclaimer
I hereby declare that all the information furnished is true to the best of my knowledge.
Languages
English
First Language
Hindi
Upper Intermediate (B2)
B2
Timeline
Clinical Data Associate
Bioscan Research
02.2024 - Current
Executive Corporate Affairs
Amneal Pharmaceuticals Pvt. Ltd.
12.2022 - 02.2024
Master of Pharmacy (Pharmaceutical Chemistry) -
Central University of Rajasthan
Bachelor of Pharmacy -
Madhav University
HSC -
GSSS
SSC -
GSSS
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