Job Description

Department- Trial Data Management CDS-GBS

Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, Raise your hand as there is an exciting opportunity waiting for you as

\xe2\x80\x9cData Manager\xe2\x80\x9d with us. \xe2\x80\x9cApply Now\xe2\x80\x9d At Novo Nordisk, we assure you will experience the best.

About the Department:

The Trial data management department was established in Bangalore, India in the month of September 2007 and has significantly grown from 10 members to a strong team of over 119 Trail Data Management professionals. It is a young, enthusiastic, and dynamic team with varied skillsets and professionals from diverse backgrounds such as pharmacy, life-sciences, physiotherapy, computer/information sciences and business administration. The key objective of the department is to ensure high quality data delivery to the stakeholders. The involvement of various groups in data management is significant in key stages of trial setup, conduct and closeout.

The Position

The Data Manager is expected to serve as a CTDM point of contact for complex trials (including new data sources) or across multiple trials. Alternatively, being specialised in a business-critical process or system and capable of applying this expertise across multiple trials. Mentor more junior colleagues and contribute with an innovative mindset that challenges the status quo. The Data Manager will be responsible for:

• Participate in and provide input to protocol outline and protocol development. Define the structure and specifications for data collection in collaboration with internal and external stakeholders (CRF, external data).
• Supervise the setup of clinical data management systems and interfaces. Create, maintain, and put into action a Data Management Plan that covers all data management activities and oversee the creation of a trial data quality plan (data checks, blinding).
• Ensure clear and concise communication with operational and functional trial partners (e.g., Data Management Systems and Standards, Biostatistics, Trial Operations, Medical & Science, Clinical Supplies, Global Safety), as well as timely follow-up. To review / understand data and make operational decisions, use data visualisation methods.
• The Data Manager will perform post- Database Lock (DBL) activities to ensure submission-ready data and resolve or escalate major issues, with assistance from the Manager of the relevant data management unit.

Qualifications

• M.Sc. /B.Sc. in Natural/Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications. A degree in computer science or equivalent professional experience.
• 2-6 Years of relevant experience in pharmaceutical or development industry and preferably with an end-to-end exposure in Clinical Data Management.
• Excellent knowledge of clinical systems used in drug development, in the field of relational database systems.
• Experience working under quality requirements such as GCP and ISO, Clinical development, and Project Management.
• Excellent written and spoken English.
• Ability to plan well and handle complex tasks simultaneously and independently.
• Analytical and result oriented.
• Good team player with communication and stakeholder management skills.
• Proactive and resilient to changes.

Working at Novo Nordisk

At Novo Nordisk, we don\xe2\x80\x99t wait for change. We drive it. We\xe2\x80\x99re 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 \xe2\x80\x93 we\xe2\x80\x99re 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). Please take note that this position is only open to external applicants. It is requested that internal candidates not apply.

Deadline

Apply before 18th May,2023.

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\xe2\x80\x99re life changing.

Novo Nordisk