Novo Nordisk
Location
Delhi | India
Job description
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.
As a Project CDP Specialist at Novo Nordisk, you will additionally be responsible for: Resposible 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. Demonstrate subject matter expertise and equip 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 being the Point of Contact for audit/inspection representing DM-CDR, to coordinate with the Audit/inspection or and ensure all the requirements are handled efficiently. Qualifications To be successful in this role, you should have the following qualifications: M.Sc / B.Sc in Life Science or comparable degree in computer science, Information Technology clinical information management, or equivalent qualifications. Minimum 12+ years of experience in the pharmaceutical industry, preferably 9+ years within clinical data management, and hands-on experience in CDISC SDTM. Expert knowledge of end-to-end clinical data management activities. Expert knowledge of computer systems involved in clinical data management and mandatory experience in programming languages (e.g., SAS/SQL/R Jupyter, etc.). Expert knowledge of AI & ML is preferable. Sound knowledge of analysis and design of business processes and functional design within the area of drug development. Extensive experience with collaboration across professional and regional borders. Participation in conferences/workshops. Demonstrated experience with project management and stakeholder management. Profound knowledge of GxP and guidelines within drug development. Advanced knowledge of relational database systems and data models. Knowledge about regulatory activities. Clear communication and facilitation of agreement between multiple stakeholders to ensure smooth end-to-end.Job tags
Salary
