Praveen Kumar Hiremath Email & Phone Number

Bengaluru Area, India

Bengaluru Area, India

Providing feedback on ‘Thinktrial' database for further upgradation. Designing eCRFs using client specific ‘Specifications and protocol’.Writing Edit check specification and implementing after client approval.Designing eCRFs, Database, Setting up Queries, Modeling Notifications, and setting up all administrative Rights and maintenance of Rights on all Users throughout the study.Maintain version control and create eCRFs directly from protocol schedule of events with overview and… Show more Providing feedback on ‘Thinktrial' database for further upgradation. Designing eCRFs using client specific ‘Specifications and protocol’.Writing Edit check specification and implementing after client approval.Designing eCRFs, Database, Setting up Queries, Modeling Notifications, and setting up all administrative Rights and maintenance of Rights on all Users throughout the study.Maintain version control and create eCRFs directly from protocol schedule of events with overview and input from supervisor. Create and update, as needed, work instruction regarding creation of eCRFs and Instructions.If handwritten annotated eCRFs are provided from CRO, computerize for clarity as requested and check annotated eCRFs against test database to verify correct data structure setup. Review, edit specification documents against the eCRFs and provide comments to clinical data manager.Provide support and assistance in generation of training materials for study specify eCRFs.Coordinate QC activities of study databases with QC specialist.To liaise with sponsors and project teams to ensure complete and accurate information is provided to the CRF design team to allow production of complete eCRFs.Identify any risks or limitations to final eCRFs and ensure these are adequately discussed with the sponsor in order to eliminate any risk that would result in the company being negatively impacted due to the content of a final CRF/eCRF.Work with other members of the project team. This includes but is not limited to the Project Manger, Sponsor, Programmer, Statistician, CRA and Data Manager.To participate in review of the draft CRF/eCRF to ensure the CRF/eCRF are complete, accurate and meet all requirements of the company and the sponsor.Be capable of understanding a protocol and providing feedback to the project team/CRF design group on design issues, with regards to the protocol requirements.Perform other duties as assigned. Show less

M Sc, Biotechnology

B Sc, Biotehnology

Schooling