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:
• Advance 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 to discuss technical issues with implementation of approved OC data structures.
• 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.
• For assigned Medical & Clinical Solutions team clinical trials initiate data load from multiple source systems (OC/RDC, IWC, Watson LIMS etc.) into the data warehouse/LSH and connect with all affected parties, Quality Manager, Data Manager, Database Programmer, CRO/CPO personnel and other Third-Party vendors.
• 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. Within Medidata RAVE EDC system, perform comprehensive DB.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• Advance knowledge/understanding and experience of applications like Oracle Clinical and standard reporting systems like CDISC/SDTM.
• Ideally 8 or more years’ experience in drug development, with at least 6 years in Data Management activities. Experience in outsourced studies or working for a CRO is desirable.
• Basic to advance knowledge of SAS, SQL, PL/SQL. Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding.
• Good organizational and project management skills. Good technical and problem-solving skills. Ability to work independently, demonstrating initiative and flexibility.
• Attention to detail and quality focused. Good interpersonal and communication skills and ability to operate effectively in an international environment.
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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