Location
Bangalore | India
Job description
Department – Phase 1 & NIS DB Design, Build & Programming, Data Management & Centralized Data Review
Are you an experienced Project CDP 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) supports 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.
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.
Working At Novo Nordisk
At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.
Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Apply Now!
Deadline
20th March 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.
Job tags
Salary
