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Location

Bangalore | India

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Job description

Department :SDTM Programming & Submission 

 

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.

About the department

Bangalore Global Development, Global Business Service (GBS), SDTM Programming & Submission team was established in April 2016 and became a separate department in July 2021. The team has a good blend of experience and fresh perspective and comprises experienced SDTM Subject Matter and Submission experts, who form the core of the team. The main purpose & objective is to ensure high quality compliant submission ready SDTM packages in close collaboration with our stakeholders across the clinical landscape, for all clinical trials within Novo Nordisk.

The Position

 

The Lead SDTM Programmer will be responsible for ensuring compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) and promote the exchange of knowledge within the organization and externally via participation in meetings/conferences.

The Lead SDTM Programmer is recognized as responsible for supporting end users and must act independently, following the strategic objectives of the standards governance bodies and the company in general. The Lead SDTM Programmer will be responsible for assisting in solving methodological or technical demanding tasks where innovation is a key element.

 

• Ensure design for clinical trials are aligned across trials within projects.
• Create the Study Data Tabulation Model (SDTM) submission package and post to publishing environment.
• Must have presented in conferences (within and outside India) and have a strong network within the pharmaceutical industry.
• Should have experience driving cross-functional initiatives with diverse stakeholders.
• Should have strong interpersonal capabilities to lead projects and people
• Maintain and ensure consistency in communication with teams and projects on standards adherence.
• Drive system releases and impact assessment, Share better practices and use of standards in alignment with Standards Developers.
• Provide business support and facilitate implementation of business processes.

 

Qualifications

 

• Bachelors or Masters in life sciences, natural sciences, pharmacy, veterinary science, engineering, clinical information management, computer science or equivalent qualifications
• Minimum 6-8 years of experience in the Life Sciences industry and preferably 4 years within Clinical Data Management and with hands on experience in Clinical Data Interchange Standards Consortium (CDISC) SDTM.
• Expert knowledge on end-to-end clinical data management activities and computer systems involved in clinical data management.
• Experience with programming languages, eg., SAS, R, Python, AI/ML
• Extensive experience with collaboration across professional and regional borders.
• Experience with communication and presentations.
• Experience in mentoring.
• Participation in conferences/workshops.
• Demonstrated experience with project management and stakeholder management.
• Profound knowledge of GxP and guidelines within drug development and regulatory activities.

 

About Novo Nordisk

 

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 61,400 people in 80 countries and markets its products in around 170 countries.

 

Contact

 

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

Apply Now!

 

Deadline

 

17th 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.

 

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Salary