Job Description

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Senior Manager

Category: Clinical Development and Medical

Location:

Bangalore, Karnataka, IN

Are you passionate about Data Management? Are you interested in delivering excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you the best at what you do? If so, "Raise your handaEUR as there is an exciting opportunity waiting for you as "Senior ManageraEUR at Novo Nordisk. "Apply NowaEUR to join our best in class team.

About the department

The Trial Data Management department in the Clinical & Data Science area (CDS) in Bangalore has a total of 85 clinical trial data managers within 180+ global team. We are organised into 6 teams with a blend of experience and fresh perspectives. The main objective of the department is to ensure high quality trial data management participation and support. Activities include

• Input to protocols
• Responsibility for data collection instruments, e.g. eCRF, patient diaries, wearables and others
• Handling and cleaning of data through the lifecycle of a trial
• Provision of data sets for external data monitoring committees and submissions
• Participation in regulatory inspections
• Managing risks and issues and effectively communicating relevant statuses to stakeholders

The department is also responsible for securing GCP, GDPR as well as regulatory compliance in processing of global clinical trial data and application of global data standards. The department works closely together with global partners and are part of global project teams.

The position

As a Senior Manager, the ideal candidate will be part of the Trial Data Management CDS GBS management team. This will involve cooperating and anticipating new challenges and needs for the department, and developing the processes in the organisation accordingly, as well as ensuring continuous improvement. The ideal candidate will be responsible for the performance of their teams and quality of their work while in compliance with ISO, SOPs and regulatory guidelines which has a direct impact on the critical time to market for new drugs .

The candidate will be responsible for all global data management activities (incl. database set-up activities, data handling and oversight) across the phase 2-4 Other Serious Chronic Diseases (OSCD) & Outcomes trials in Novo Nordisk. Additional responsibilities include:

• Contribute to the global resource allocation, ensuring that trials are supplied with Clinical Trial Data Managers in a timely manner.
• Ensure a continuous improvement mind-set by participating in quality activities, feedback sessions and lessons learned.
• Plan and lead department meetings, raise relevant issues and inform relevant parties, and contribute to the general information flow in the area.
• Manage the department according to the Novo Nordisk way including developing the employees and the team to meet Novo Nordisk business needs.
• Communicating with various stakeholders and ability to work in a global environment.
• Keeping up with industry trends to drive innovation and change within the department.

Experience

• 12+ years' experience with minimum 5 years' experience with clinical trial conduct, and 3 years within the pharmaceutical industry. Minimum 2 years of preferable experience with project or team management.
• Bachelor's degree or comparable degree in any medicine, natural science, nursing, pharmacy, veterinary science, clinical information management or computer science.
• Profound knowledge of drug development and basic medical terminology.
• Knowledge of the data structures in Clinical Trial Management System, Electronic Data Capture, Clinical Data Management System and/or data warehouse system.
• Experience with development of clinical standards and knowledge of external standards.
• Experience with collaboration across professional and regional borders.
• Regular experience with communication and presentations.
• In-depth knowledge of GxP and guidelines within drug development.
• Experience working under quality requirements such as Good Clinical Practices and ISO.

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

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

Deadline

Apply on or before: 28th November, 2022

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.