Novartis Pharmaceuticals 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 key responsibilities:
Your responsibilities include, but are 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
• Manage local lab set up for the Clinical Database as applicable
• Under supervision ensures consistency of assigned trials with program level standards
• Understands third party data requirements and begins 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
• Ensures activities that are performed are done with quality and understanding of the process. Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed
• With support from the Trial Data Manager develops proposals to resolve issues that may occur during the running of assigned trials. With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced
• Has a working knowledge of FDA and ICH guidelines. 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\n\n\n\n
Clinical Data Manager
• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Fluent English (oral and written).
• Strong technical skills,
• Fluent English verbal and written
• Ideally 3 years experience in Drug Development with at least 2 years in Clinical Data Management
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
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