Karthikeyan Alappan Email & Phone Number | Over several years experience in Clinical Research within Clinical Trials. Worked on Early Phase, Multiple Phase II and Number of Phase III Global studies, as well as CRO experience. In depth knowledge of ICH GCP, FDA, ICH guidelines, Regulatory Requirements& Submissions on Clinical Trial Conduct, Serious Adverse Event Reporting. Well versed with Global Supply Chain from Manufacturing till delivery at Clinical Site with various IT Tools and Systems. Volunteered on the Integrated Drug Supply System, Expert on testing & validating IRT Systems for onboarding, Quality Assurance responsible for Web Based Release Platform, Deviation & Change Control Process management (Certified Investigator & QA Approver). Handled internal Self-Inspections, Sponsor Audits and Regulatory Audits. Expert on Clinical Trial Management activities including study start up and monitoring, Good Clinical Practice GCP preparation, regulatory monitoring, investigator initiated study reports (IRB), study close out, document review, site auditing and reporting. Based on these experiences, currently exploring on SAP S4 HANA Study Master and Demand Forecasting modules.

Karthikeyan Alappan

Over several years experience in Clinical Research within Clinical Trials. Worked on Early Phase, Mu...
Hyderabad, Telangana, India

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Karthikeyan Alappan’s Phone Numbers +1 212-830-****

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Karthikeyan Alappan’s Location Hyderabad, Telangana, India

Karthikeyan Alappan’s Current Industry Tenthpin Novartis Healthcare

Karthikeyan Alappan’s Prior Industry Sristek Consulting | Tmi Australia

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Trd Quality Project Manager

Present

Advisor

2022-12-01 00:00:00 - Present

Manager Site Demand Planning

2015-05-01 00:00:00 - Present

Lead Clinical Research Associate

2008-10-01 00:00:00 - 2012-12-01 00:00:00

Clinical Research Associates

2006-01-01 00:00:00 - 2008-01-01 00:00:00

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Karthikeyan Alappan is a Over several years experience in Clinical Research within Clinical Trials. Worked on Early Phase, Multiple Phase II and Number of Phase III Global studies, as well as CRO experience. In depth knowledge of ICH GCP, FDA, ICH guidelines, Regulatory Requirements& Submissions on Clinical Trial Conduct, Serious Adverse Event Reporting. Well versed with Global Supply Chain from Manufacturing till delivery at Clinical Site with various IT Tools and Systems. Volunteered on the Integrated Drug Supply System, Expert on testing & validating IRT Systems for onboarding, Quality Assurance responsible for Web Based Release Platform, Deviation & Change Control Process management (Certified Investigator & QA Approver). Handled internal Self-Inspections, Sponsor Audits and Regulatory Audits. Expert on Clinical Trial Management activities including study start up and monitoring, Good Clinical Practice GCP preparation, regulatory monitoring, investigator initiated study reports (IRB), study close out, document review, site auditing and reporting. Based on these experiences, currently exploring on SAP S4 HANA Study Master and Demand Forecasting modules.