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@anandkharwar
Versatile Clinical Data Manager with expertise in data management.
I am a Clinical Data Manager with extensive experience in managing databases and ensuring the accurate collection of key information. My proficiency in industry-standard computer programs and applications has enabled me to specialize in cost-effective data management procedures. I have successfully coordinated international data teams and streamlined workflows to enhance data collection efficiency.
Throughout my career, I have implemented innovative solutions, such as a risk-based monitoring approach that significantly reduced on-site monitoring costs while maintaining data quality. I take pride in mentoring junior data managers, advocating for strict adherence to data protection standards, and pioneering the use of CDISC standards to improve data submission consistency.
With a strong background in clinical research and regulatory affairs, I am committed to ensuring compliance with regulations such as GDPR and FDA guidelines. My goal is to leverage my skills and experience to contribute to impactful clinical studies and drive data excellence in the healthcare industry.
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Work history, roles, and key accomplishments
IQVIA
Sep 2022 - Present (3 years 2 months)
Coordinated international data teams for a multi-center study, enhancing data quality and meeting regulatory deadlines. Streamlined EDC workflows, reducing manual data clean-up by 25%. Implemented risk-based monitoring, cutting on-site costs by 20%, and pioneered CDISC standards, improving data submission consistency by 10%. Mentored junior managers and ensured 100% compliance with GDPR.
LabCorp
Nov 2021 - Sep 2022 (10 months)
Reviewed edit check specifications and prepared data transfer agreements. Coordinated with DMPM and team members for study-related activities, ensuring timely follow-ups and input.
ICON
Apr 2019 - Oct 2021 (2 years 6 months)
Managed Rave database for oncology studies, focusing on locking and freezing activities. Handled daily queries and vendor issues, coordinating with DMPM and preparing weekly reports.
TCS
Sep 2017 - Apr 2019 (1 year 7 months)
Prepared CRF specifications and completion guidelines. Conducted validation writing and quality control, managed discrepancies, and coordinated with CRA monitors for study-related issues.
Medical Store
Dec 2014 - Sep 2017 (2 years 9 months)
Guided patients on prescribed medications and managed records in software. Dispensed medicines for common conditions, ensuring accurate record-keeping.
Cognizant Technology
Jun 2012 - Dec 2014 (2 years 6 months)
Assisted lead data managers in preparing reports and validating clinical data. Coordinated data management activities and archived documentation, ensuring compliance with study requirements.
Degrees, certifications, and relevant coursework
Master of Science, Clinical Research and Regulatory Affairs
2011 - 2013
Completed a Master of Science in Clinical Research and Regulatory Affairs, focusing on the principles and practices of clinical research, regulatory compliance, and data management in the healthcare sector.
Bachelor of Pharmacy, Pharmacy
2006 - 2010
Earned a Bachelor of Pharmacy, gaining foundational knowledge in pharmaceutical sciences, drug development, and patient care.
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