Novartis Pharmaceuticals Hiring for Clinical Data Manager at Hyderabad, AP, India Full Time

330411BR Job ID: 330411BR 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: • As Clinical Data Manager (CDM) provide data management input on Clinical Trial teams. May have the role of TDM on small low complexity trials. • Performs DM activities for start-up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP) Data Review Plan (DRP) and performing user acceptance testing (UAT) as applicable. • Under supervision ensures consistency of assigned trials with program level standards. With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced. • Understands third party data requirement and begin to gather an understanding of new technologies that may be used in the course of clinical trials. • Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable. • Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed. Manage local lab set up for the Clinical Database as applicable. • Has proven ability to use the tools available to generate listings for data review and where necessary provides these to the study teams. Generates the study status reports for use at Clinical trial team meetings. Has a working knowledge of FDA and ICH guidelines. nnnn Position Title: Clinical Data Manager Minimum requirements: What you’ll bring to the role: • Contribute to the achievement of overall goals as set each year by Global Head, Data Operations, GDO. • All assigned project deliverables meet targets for quality, time, and productivity in adherence with business standard operating procedures. • No critical audit findings due to Data Management. • Minimum Education: University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree. Desirable: 3 years’ experience in Drug Development with at least 2 years in Clinical Data Management. Why Novartis? 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! Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Research & Development Division: Global Drug Development Business Unit: GDO GDD Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind Commitment to Diversity & Inclusion:: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No