Novo Nordisk
Data Manager
Job Description
Trial Data Management
Are you ready to take on a challenging role as a Data Manager? Do you have experience in clinical trial data management and a passion for ensuring high-quality data delivery? Join our Trial Data Management team in Bangalore, India, and make a difference in the field of healthcare. Read on and apply today for a life-changing career.
The Position
The Data Manager is entrusted with the pivotal role of serving as the Clinical Trial Data Manager (CTDM) within our Trial Squad. This role involves a broad spectrum of responsibilities geared towards efficiently managing all global data management activities and proactively anticipating new challenges. Additionally, the Data Manager is accountable for project management and ensuring end-to-end trial delivery from data management (DM). On complex trials, the Data Manager is expected to fill a supporting CTDM role, while also taking on the role of CTDM Point of Contact (PoC) for simpler trials.
As a Data Manager at Novo Nordisk, you will have the opportunity to:
- Responsible for DM-related project management and oversight of the end-to-end clinical trial (s) on which they have been assigned at any given time. DM-related project risk identification, issue prevention and resolution, decision facilitation, and management reporting.
- Be accountable for end-to-end trial delivery from data management, ensuring project goals, plans, and assigned activities are met.
- Manage and oversee the entire clinical trial, identifying and addressing project risks, facilitating decision-making, and providing management reporting.
- Ensure the availability of clinical data that meets regulatory requirements, quality standards, and data standards.
- Set up clinical data management systems and interfaces, create and execute a Data Management Plan, and establish a data quality plan for each trial.
- Perform post-database lock activities to ensure submission-ready data and resolve any major issues. Maintain clear and concise communication with operational and functional trial partners.
Qualifications :
To be successful in this role, you should possess the following qualifications:
- MSc/BSc in Natural/Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications
- Preferably 2- 4 years of data management experience the majority of this within Pharma Industry or Development.
- Excellent knowledge of clinical systems used in drug development, in the field of relational database systems.
- Strong knowledge and experience in data systems management, data analysis and review, and data quality and integrity assurance.
- Proficiency in data acquisition, transformation, and harmonization, as well as regulatory submission package input.
- Familiarity with data management and data analytics tools, trial regulations and legislation, and data governance and security.
- Understanding of data architecture and business communication.
- Experience with Good Clinical Practices (GCP) and/or Good Laboratory Practices (GLP) data-handling procedures and guidelines.
- Knowledge of drug and disease terminology and the ability to review clinical research protocols, reports, and statistical analysis plans.
About the department
The Trial Data Management department was established in Bangalore, India in September 2007 and has since grown significantly. Our team consists of young, enthusiastic, and dynamic professionals from diverse backgrounds such as pharmacy, life sciences, physiotherapy, computer/information sciences, and business administration. We are dedicated to ensuring 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.
Working At Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions worldwide and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees worldwide. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life-changing.
Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Apply Now!
Deadline
15th April, 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.