Project CDP specialist

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:

• 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 Contact for audit/inspection representing DM-CDR, to coordinate with the Audit/inspection 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 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
• 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.

Working At Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life-changing.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Apply Now!

Deadline

30th April,  2024.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.