Sandhya A. Email & Phone Number

Hyderabad, Telangana, India

Hyderabad, Telangana, India

Greater Hyderabad Area

The IRT Manager (IRTM) is accountable for managing all technical and operational aspects of the Novartis Interactive Response Technology (NIRT) system. The IRTM ensures optimal utilization and timely delivery of the high-quality NIRT system in strict accordance with protocol requirements and in consultation with the Clinical Trial Supply Manager (CTSM) and Clinical Trial Team (CTT). Role & Responsibilities 1. Lead and main contact for NIRT studies in maintenance phases, ensuring protocol requirements are met within NIRT platform 2. Evaluate draft protocol / protocol synopsis to determine if trial is a candidate for NIRT or Standard Interactive Response Technology (SIRT) 3. Lead completion and approval of 'Parameter Specifications' for study systems, by translating IRT needs (per protocol) into high quality user requirements to support development of NIRT system 4. Conduct peer review of design documentation for study design created by IRT study owners, ensuring design matches protocol requirements 5. Manage technical aspects of system lifecycle (SLC), acting as lead through configuration and validation of NIRT system (in collaboration with External Service Provider) through setup and “Go-Live” 6. Support NIRT Help Desk training, performance, and continuous evolution of the positive patient and clinical site experience with Novartis 7. Lead problem solving and resolution efforts by assisting with issue identification, resolution, documentation, and escalation (NIRT super user, driving root call analysis of system and site issues) 8. Ensure compliance to protocol and performance to the NIRT standard operating procedures (SOP)s 9. Partner with other IRTMs on a cross-functional basis to develop and implement business process improvement activities 10. Produce and distribute status, tracking and key reports for internal and external team members and senior management

Novartis-Hyderabad

Responsibilities: IRT (Interactive Response Technology) (IVRS/IWRS)• Evaluate planned trials as potential candidates for IRT; assess risks, costs and benefits of utilizing IRT• Responsible for the development, initiation, maintenance and close-out of IVR/IWR• Liaison between key stakeholders: IRT Vendors and Clinical Trial Teams (CTT), Global clinical supplies (GCS), Biostatisticians, Data Management and Clinical Quality Assurance (CQA) to ensure the business needs of the key stakeholders (CTTs/Investigator sites) are met for the development of IRT.• Responsible for completing Decision Grid as required;• Review overview of costing proposal from vendors• Perform Vendor Bid Analysis for procurement recommendations to clinical trial teams• Support the CTT/GCS in the selection of the preferred provider, user requirement specifications (URS) and other relevant activities for IVRS initiation• Plan, perform and document user acceptance testing (UAT) of all systems including report facilities with support of CTT prior to system going live • Ensure approval of related documents• Track usage of systems; assist in the development and implementation of strategy to increase/improve usage of systems.• Conduct worldwide training for new hires as well as SOP and Business Guidance training on the processes of IRT• Ensure constant information flow between key stakeholders: CTTs and IRT Vendors• Issue escalation process with relevant stakeholders such as QA, CTT, Statistician

Bangalore

Obtain and maintain essential documentation in compliance with ICH-GCP, and local regulations both inthe office and at site. Actively participate in Study Delivery Team meetings. Contribute to the selection of potential investigators. Contribute to national Investigators meetings. Initiate, monitor and close study sites. Share information on patient recruitment and study site progress within Study Delivery Team. Update data from centers in a timely manner. Manage study supplies at study site level. Manage study drug supplies and accountability at the study sites. Train, support and advice Investigators in study related matters. Patient recruitment and retention tools such as newsletter, flyers, appointment reminders, translated in locallanguages upon Ethics committee approvals. Review paper/electronic patient reported outcomes Perform source data verification. Review lab data/ reports with quintiles lab source system and report any discrepancies Ensure accurate and timely reporting of Serious Adverse Events. Ensure data query resolution. Prepare for activities associated with audits and regulatory inspections. Provide input into process development and improvements. No. of on-Site Monitoring Visits – 150-170 Track and manage agreed payments at study site level. Keep track on research intelligence in local market. Contribute to process improvements: work with other members of the organisation to share knowledge,experience and best practices. Work with Data Management to ensure the quality of the study data

Hyderabad Area, India

Understanding the study Protocol, CRF and related documents. Centre Identification. Familiarizing with SOP’s for the studies. Interaction with the Investigators. Organizing Investigator Meets, Travel plans. Monitoring that the physician adheres to Good Clinical Practices and the study protocol. Performing study drug accountability; Verifying the documentation of the informed consent process for each study subject; Ensuring that non-serious and serious adverse experiences are properly documented and reported. Reviewing the case report form against the subject's medical record for completeness and accuracy; Ensuring the filing and maintenance of the required regulatory documents Collection of all completed CRF’s Collection of Adverse event and serious adverse event forms. Collection of ePRO (electronic patient reported outcomes) questionnaire from the sites during monitoringvisits. Maintaining timelines. Handling DCF’s ( Data correction forms) Organize the result meets. Completed 4 Phase IV trials-IMPROVE, IMPROVE LIFE, DIABESITY, A1CHIEVE studies.