Hyderabad, Telangana, India
Successfully completed over 8 years in the field of Clinical Domain. Gained experience in handling relational databases, complex and critical data with the help of various analytical tools and software. Possess good communication and leadership skills in various teamwork activities.
-Lead LSH/Data Loading activities for assigned/Project level activities for phase I to IV clinical studies in Novartis Global Drug Development. -Lead in the review of Data Transfer specification documents and provide comments if required. -Perform Data Loading activities so that data flow is available once the third party data is obtained from external vendors. Address QC findings prior to Production Loads. -Responsible for Data Loading for all models (both inbound/outbound for both Legacy/future models). -Responsible for Study Conduct activities that includes Conformance of Clinical data to internal Novartis data formats and continuous flow of data to downstream systems. Perform Masking/Blinding activities as per the Data management Plans and perform testing before providing to the stakeholders -Communicate with all affected parties including Quality Manager, Data Manager, Database Programmer, CRO Personnel and Third Party Vendors. -Good understanding of Metadata management and impact of Data elements within Metadata and potential impact on Study deliverables. -Participate in all Subject matter expert (SME) activities and help on any functional testing activities. -Build and maintain effective working relationship with cross-functional team. -Ensure timely and quality development and validation of Deliverables for study-documents according to specifications. -Responsible for quality control and audit readiness of all Setup activities and deliverables as well as accuracy and reliability of setups. -Under minimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance - Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. with Data Management team as member of the extended Clinical Trial Team (CTT).
- Contribute to LSH and Data Loading activities as Clinical Programmer for phase I to IV clinical studies in Novartis Global Drug Development. - Participate in the review of Data Transfer specification documents and provide comments if required. Also perform Data Loading activities so that data flow is available once the third-party data is obtained from external vendors. Address QC findings prior to Production Loads. - Responsible for Data Loading for all models (both inbound/outbound for both Legacy/future models). - Responsible for Study Conduct activities that includes Conformance of Clinical data to internal Novartis data formats and continuous flow of data to downstream systems. Perform Masking/Blinding activities as per the Data management Plans and perform testing before providing to the stakeholders. - As part of the Setup activities, responsible for the maintenance and daily operational support that includes Data processing activities during Study conduct like reviewing Job Logs, address Error/Failure notifications, blinding process of Third-Party Data. - Communicate with all affected parties including Quality Manager, Data Manager, Database Programmer, CRO Personnel and Third-Party Vendors. - Have good understanding of Metadata management and impact of Data elements within Metadata and potential impact on Study deliverables. - Ensure timely and quality development and validation of Deliverables for study-documents according to specifications. - Responsible for quality control and audit readiness of all Setup activities and deliverables as well as accuracy and reliability of setups.
-Experienced in Life Sciences Domain working for one of top 5 Pharmaceutical Client. -Developed various types of Clinical Reports by analyzing Clinical datasets using Business Intelligence software and predicting the results of the clinical events. -Worked in Clinical Data Management with cross functional experience in Study Setup and development of Clinical reports using SAS and SQL Programming language. -End to End handling of Clinical Study Set up and Data Management which involves transformation of complex raw data into simpler datasets and delivering with the desired end result. -Facilitated Data extraction, Data interpretation and Analysis using SAS and Cognizant In-house Application for generating various kinds of reports. -Responsible for adhoc analysis by understanding the client requirement and working closely with onsite member to provide impactful deliverable in stringent timelines -Possess strong communication, analytical and presentation skills.
-Trained in SQL, Base SAS -Worked closely with one of the top Pharmaceutical client and gained experience in Clinical Domain.
Developed a Remote Administration and Maintenance Application for Superx Linux Operating System.