Murahari Nanda
Clinical Data Manger @Dsg, Inc
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WORK HISTORY
Clinical Data Manger @Dsg, Inc
Bengaluru, IN
Strong experience in working with different phases of clinical trials from Phase I- Phase IV and experience in managing start up to close out EDC trials.• Completed 2 Study Startup Phase to Close Out Phase.• Worked extensively during study start up on clinical data base designing and CRF designing in accordance with CDISC/ CDASH guidelines• Strong knowledge in creating edit check specifications and proficient in developing test scripts and performed user acceptance testing (UAT) according to test plan.• Developed and maintained key documents such as eCRF completion guidelines, Data Management Plans (DMP), Data Validation plans, Data Transfer agreements (DTA) and other DM specific documents and made sure they are followed throughout the project life cycle.• Good Knowledge in Medical terminology and experienced in coding with Med DRA and WHO DD.• Had an Experience in working Central Lab Reconciliation.• High work experience on query management, offline listings, performed SAE reconciliation and external vendor data reconciliation.• Experience in working on Medidata Rave EDC, i-Medrio, eCaselink (EDC from DSG).• In-depth knowledge of drug development process, clinical trial process, data management regulations and good knowledge and commitment of adherence to ICH_GCP guidelines, US FDA safety reporting guidelines.• Ensures all steps leading up to a quality database release are met in accordance with the clinical data management timelines.• Having good coordination and interactions with the clients, vendors and team members of clinical operation, safety and regulatory.• Possess strong ability to quickly adapt to new applications and platforms.• Excellent in multi-tasking, verbal and written communication skills and strong personal communication.
EDUCATION
Sri Padmavati School of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Raghavendra Institute of Pharmaceutical Education & Research, Anantapur
Diploma in Pharmacy, Pharmacy
Sri Krishnadevaraya University (SKU), Anantapur
M-Pharmacy, Pharmacology
ABOUT MURAHARI NANDA
Strong experience in working with different phases of clinical trials from Phase I- Phase IV and experience in managing start up to close out EDC trials.• Completed 2 Study Startup Phase to Close Out Phase.• Worked extensively during study start up on clinical data base designing and CRF designing in accordance with CDISC/ CDASH guidelines• Strong knowledge in creating edit check specifications and proficient in developing test scripts and performed user acceptance testing (UAT) according to test plan.• Developed and maintained key documents such as eCRF completion guidelines, Data Management Plans (DMP), Data Validation plans, Data Transfer agreements (DTA) and other DM specific documents and made sure they are followed throughout the project life cycle.• Good Knowledge in Medical terminology and experienced in coding with Med DRA and WHO DD.• Had an Experience in working Central Lab Reconciliation.• High work experience on query management, offline listings, performed SAE reconciliation and external vendor data reconciliation.• Experience in working on Medidata Rave EDC, i-Medrio, eCaselink (EDC from DSG).• In-depth knowledge of drug development process, clinical trial process, data management regulations and good knowledge and commitment of adherence to ICH_GCP guidelines, US FDA safety reporting guidelines.• Ensures all steps leading up to a quality database release are met in accordance with the clinical data management timelines.• Having good coordination and interactions with the clients, vendors and team members of clinical operation, safety and regulatory.• Possess strong ability to quickly adapt to new applications and platforms.• Excellent in multi-tasking, verbal and written communication skills and strong personal communication.
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