Novartis Pharmaceuticals Sr. Clinical Data Manager in Hyderabad, AP, India
500 studies across multiple therapeutic areas. This is the exposure and scale our Data Management group has. We are on our journey to Reimagine medicine with Data and Digital and our team is focused on delivering data which is fit for purpose.
Innovation at scale is one of the strategic pillars for us as a Clinical Data Management team and you will have an opportunity to apply your skills to experiment and innovate ways to transform the Clinical Data Management process in Drug Development.
We are looking for individuals with end to end experience in clinical data management. You will play a key role in providing leadership to various teams and developing cross-functional data cleaning strategies.
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
• Performs DM hands on activities during the course of the study. 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\n\n\n\n
Sr. Clinical Data Manager
• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree with Ideally 5 years experience in Drug Development with at least 4 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
• Excellent verbal and written skills
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Research & Development
Global Drug Development
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