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About the Role
Major accountabilities:
Contibute to LSH and Data Loading activities as Associate Clinical Database Programmer for phase I to IV clinical studies in Novartis Global Drug Development. 2. Understanding different formats that can be supported for both Inbound and Outbound data. 3. 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. 4. Should be able to review job logs, Error/failure notifications, follow Blinding process of Third Party data. 5. Build and maintain effective working relationship with cross-functional team. 6. Comply and adhere to Novartis SOPs with standards and processes to support the LSH Setup and Data Loading Activities. 7. Ensure timely and quality development and validation of Deliverables for study-documents according to specifications. 8. Responsible for quality control and audit readiness of all Setup activities and deliverables as well as accuracy and reliability of setups. 9. Extend knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM), attend functional meetings and trainings.
Key performance indicators:
Quality and timeliness of statistical programming deliverables and contributions as assessed by the Lead Programmer/Trial Programmer and the functional/operationalmanager.
Effectiveness of communication and team behaviors as assessed by the cross-functional team members.
Minimum Requirements: Education (minimum/desirable):
Languages: Experience/Professional requirement: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Fluent English (oral and written).
1. 0 to 2 years of experience in a programming role preferably supporting clinical trails or atleast initial work experience as Intern/Trainee.
2. Basic understanding of Mapping, ETL or Data Warehousing activities.
3. Basic understanding of Metadata Standards Management like CDISC SDTM, LSH.
4. Excellent knowledge of Global Clinical Trial Practices, procedures and Data presentation.
5. Basic understanding of related applications that are Data collection tools (like OC, Rave) and ancillary data.
6. Basic understanding of Regulatory requirements.
7. Basic communications and negotiation skills, ability to work well with others globally.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
