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Clinical Trial Data Manager

1 month ago

Bengaluru, India Novo Nordisk Full time

   

Department: Data Management & Centralised Data Review

 

Are you ready to take on a challenging Clinical Trial Data Manager role? 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 healthcare field. Read on and apply today for a life-changing career.

 

The Position

 

The Clinical Trial Data Manager is entrusted with serving as the Clinical Trial Data Manager (CTDM) within our Trial Squad. This role involves a broad spectrum of responsibilities to manage all global data management activities efficiently and proactively anticipate new challenges. Additionally, the Clinical Trial Data Manager is accountable for project management and ensuring end-to-end trial delivery from data management (DM). On complex trials, the Clinical Trial Data Manager is expected to fill a supporting CTDM role while also taking on the CTDM Point of Contact (PoC) role for simpler trials.

 

As a Clinical Trial Data Manager at Novo Nordisk, you will have the opportunity to:

 

  • Responsible for CDM-related project management and oversight of the end-to-end clinical trial (s) on which they have been assigned at any given time. CDM-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 the 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

 

Our Clinical Data Operations & Insights group is about 400 professionals spanning across India, Denmark, and North America. Data Management sits in Development where we manage clinical drug development worldwide, ensuring that the process lives up to uniform global standards, regulations, and business ethics while delivering viable products that make a difference to patients and ultimately benefit society. Our newly formed Data Review and Cleaning group sits within the Data Management & Centralised Data Review Department led from our Bengaluru site. The Data Review and Cleaning group has been set up to centralize and modernize the data review and cleaning processes, implement new methodologies, and develop innovative toolkits supporting the transformation.

 

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

10th June, 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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