- Responsible for Implementation and adherence to Project standards template in EDC and DMW.
- Align with the PDMs to understand the project requirements (CRF and external data) for new programs/projects.
- Ensure the design and set-up of study databases for clinical trials are aligned across trials within the project, including new therapeutic areas.
- Identify and implement best practices within the assigned project area as well as the global DM team.
- Responsible for being the point of contact during Audits and Inspections for the respective allocated therapy/project area. Responsible for being the Point of
Project CDP specialist - Bengaluru, India - Novo Nordisk A/S
Description
Department – Data Management & Centralized Data Review
Are you an experienced Project Clinical Data Programming Specialist with a strong background in the pharmaceutical industry? Do you have expertise in CDISC SDTM and a passion for driving quality set-up deliverables across the value chain? If so, we have an exciting opportunity for you to join our Data Management & Centralized Data Review team in Bangalore. Read on to learn more and apply today for a life-changing career.
About the department
Data Management & centralized Data Review (DM & CDR) support trials by comprehensive data management solutions in Phase 1 and transforming clinical data review through next-gen tools, data review techniques, and risk-based approach across the portfolio, resulting in improved data quality, speed & increasing efficiency.
The Position
The Project Clinical Data Programmer Specialist is overall accountable and responsible for implementation and adherence to project standards template in EDC and DMW. Demonstrates subject matter expertise and equips in-depth knowledge and experience from trial outline to Submission. Responsible for being the point of contact during Audits and Inspections for the respective allocated therapy/project area. Responsible for performing/implementing various tasks related to Automization, Robotics, AI, Machine Learning. Provide expert process inputs and perform on-the-job mentoring and demonstrating subject matter expertise and equip in-depth knowledge and experience from trial outline to submission.
As a Project CDP Specialist at Novo Nordisk, you will additionally be responsible for: