Principal Analyst, Database Operations(Rave & Custom functions)

328027BR
Oct 12, 2021
India

Job Description

5! The number of projects you will be leading to develop our growing pipeline of Gene Therapy products. We are looking for an experienced professional in the area of drug product development for Gene Therapy-based drug products, with special focus on viral vectors. As a member of Pharmaceutical Development in the Cell and Gene Therapy Development Unit, Technical Development NBEs, you will play a key role in the development of parenteral dosage forms of viral and non-viral vectors, for gene therapy, for preclinical and clinical studies, as well as in the development of market formulations.


Your key responsibilities:
Your responsibilities include, but not limited to:

• Basic knowledge in OC, LSH, SDTM and also carries good understanding of data standards who can lead/assist the development, maintenance and implementation of standards. Work with the Governance/approval Board and other DB operations associates and/or members of vendor metadata team.

• Perform comprehensive DB Set up Plan and execute full go live of DB set up. Overall, will ensure quality DB set up within Medidata RAVE EDC system.


• Perform impact analysis for proposed modifications to existing domains, permitted choices for discussion with Governance as necessary. Support development and testing of all new Medical & Clinical Solutions team Library objects needed for clinical studies.

• Document, support development, review and maintain global library copy groups of DCMs, DCIs, Procedures, Views, maintain Form Layout Templates, Extract Macros and Key Templates DCI books for reuse of standard pages for individual trials.


• Contribute to the review of global SOPs. Ensure alignment between OC Global Library Objects and Metadata Repository.

• Understanding and Leading the Life Science Data Hub (LSH) programming activities for all new Medical & Clinical Solutions team projects implemented on Novartis Clinical Data Standards platform.


• For studies in scope initiate data extraction, pre-conformance, conformance and post-conformance of clinical data into NCDS standards based on study conformance plan and ensure data refresh as per the schedule. Review Data Transfer Specifications (DTS), grant access to vendor/CRO for loading data into IWC.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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CTS
NBS CONEXTS
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
328027BR

Principal Analyst, Database Operations(Rave & Custom functions)

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