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

328243BR Job ID: 328243BR 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 responsibilities: Your responsibilities include, but are not limited to: • Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed. • Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes. • Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards. • 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). • Manage local lab set up for the Clinical Database as applicable. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM). Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation. Supports and assists Junior staff for assigned trials. • Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner. Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence. • Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks). Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines. nnnn Position Title: Sr. Clinical Data Manager Minimum requirements: What you’ll bring to the role: • Achieve overall goals as set each year by Global Head, Data Operations, GDO and Group Head, Data Management. • 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. • University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. 4 years’ experience in Drug Development with at least 3 years’ in Clinical Data Management. • Ability to work under pressure demonstrating agility through effective and innovative team leadership • Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders • Excellent problem-solving skills 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! Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons. 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 team’s representative of the patients and communities we serve. Shift Work: No Early Talent: No