Job Description

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Manager/ Senior Manager - SDTM

Category: Data & AI

Location:

Bangalore, Karnataka, IN

Department - SDTM Programming & Submission

Are you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status-quo in a friendly and open-minded way? If so, there is a job opportunity waiting for you as our new Manager. At Novo Nordisk, we will challenge you to do the best work of your life. Apply Now.

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 SDTM Programming & Submission leader is responsible for the planning and execution of SDTM Programming & Submission activities related to Clinical projects. As a people manager and empowered leader working in a matrix organization, the ideal candidate drives and leads the SDTM Programmer team to ensure inputs to Data collection requirements, SDTM mapping, and SDTM submission packages. An ideal candidate participates in defining and implementing new processes and tools to keep Novo Nordisk in compliance with regulatory requirements, while setting directions and managing the SDTM Programmer team in a respectful and empathetic manner to meet the department and organization\'s business goals. The Manager also assists the unit head in optimal resource management and budgeting, develops, coaches, and supports employees to achieve higher levels of professional competency for current and future roles and responsibilities, and promotes continuous improvement and quality mindset with a focus on compliance to Novo Nordisk quality management system. Strong leadership, communication, people development, and organizational skills are essential for success in this role.

• The manger is responsible for timely and high quality deliverables, Planning, and execution of SDTM Programming & Submission activities for Clinical projects and makes independent decisions.
• Lead the SDTM Programmer team, Data collection requirements, SDTM mapping, and submission packages.
• Develop, coach, and support employees to achieve higher levels of professional competency and promote continuous improvement and quality mindset.
• Protect a proper balance between work, personal development and life for the SDTM Programmers and self.
• Define and implement new processes and tools to ensure Novo Nordisk compliance with regulatory requirements
• Manage the SDTM Programmer team to meet department and organization\'s business goals e.g., audits & inspections, insourcing, outsourcing etc.)
• Assist unit head in optimal resource management and budgeting.
• Nurturing synergy in collaboration with cross functional teams and foster cohesive work environment to enhance overall project success.

Qualifications:

• Bachelor\'s degree / Master\'s degree in Computer Science or equivalent in related field such as information science, life science, medicine, natural science, data science, nursing, pharmacy, veterinary science, clinical information management, etc. or equivalent professional experience.
• Minimum 2-3 years and preferably 4-5 years\' experience in Team Management, with a focus on people development and empowerment.
• Proven ability to lead by example in a respectful and empathetic manner, with a proactive and solution-oriented approach to challenges.
• Excellent communication and presentation skills, with the ability to motivate and engage the team through good coaching and counselling skills.
• Profound knowledge of drug development, including ICH GCP, basic medical terminology, and relevant regulatory requirements.
• Experience with the development of clinical standards and knowledge of external standards.
• Strong information technology and Clinical Data Management Systems experience.
• Adaptable and flexible with the ability to multitask and deliver results, with very good organizational management skills.
• Excellent negotiation, collaboration, and stakeholder management skills, with very good project management skills.

Working at Novo Nordisk

At Novo Nordisk, we don\'t wait for change. We drive it. We\'re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales - we\'re all working to move the needle on patient care.

Contact

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

Internal candidates are kindly requested to inform their line Manager before applying.

Deadline

Apply before 4th February, 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.

Novo Nordisk