Novartis Job Opening for Clinical Data Scientist post apply Now
Clinical Data Scientist
India
About the role
Clinical Data Scientist
Location – Hyderabad/ Mumbai
About the Role:
Provide timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.
Key Responsibilities:
• 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 performimg 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 abiity 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
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential Requirements:
• Education (minimum/desirable): University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Desirable Requirement:
• 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 Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
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.
Division  Development
Business Unit  GCO GDD
Work Location  Hyderabad, AP
Company/Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type  Full Time
Employment Type Regular
Shift Work  No
Early Talent  No
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