Principal CDR Specialist

Are you passionate about transforming the clinical data review into clinical data insights and ensuring data integrity and compliance with regulatory requirements? Do you have extensive experience in data management within the pharmaceutical industry? We are looking for a Principal Centralized Data Review Specialist to join our growing Clinical Data Operations & Insights (CDOI) team at Novo Nordisk. If you are ready to take on a challenging role and make a difference in the field of clinical data management, read on and apply today for a life-changing career.

The position

The Principal CDR Specialist is expected to independently lead function level initiatives in Data Management & Centralizzed Data Review and across CDOI. This role is expected to be highly specialised in multiple business critical processes and systems and capable of applying this expertise across multiple highly complex trials.

As a Principal Centralized Data Review Specialist, you will have the opportunity to:

• Lead the development and execution of risk- based data review strategies to ensure data integrity and compliance with regulatory requirements.
• Drive transformation of data review processes to enhance efficiency, speed and quality.
• Evaluate new technologies and platforms for their suitability in data review activities, ensuring alignment with departmental goals and objectives.
• Assess vendors and service providers for their capabilities in supporting centralized data review functions, including negotiation of contacts and service level agreements, if needed.
• Collaborate with cross functional teams to design and implement innovative data review models that leverage advanced analytics and automation.
• Provide strategic guidance and leadership in the implementation of risk-based data review initiatives, including training and support for staff.
• Stay abreast of industry trends, best practices and regulatory developments related to centralized data review and incorporate relevant insights into departmental strategies.
• Project risk identification, issue prevention and resolution, decision facilitation and management reporting.
• Liaise with DM&CDR leadership for the newer initiatives in sight.
• Coach and mentor team members.

Qualifications

To excel in this role, you should possess the following qualifications:

• Minimum requirements often PhD with 8+ years relevant experience or Masters with 12 + years relevant data management experience and the majority of this within Pharma Industry or Development.
• Profound experience of working with clinical systems used in drug development.
• Solid knowledge in the field of relational database systems.
• In-depth knowledge of the full value chain in clinical development.
• Profound project management experience and experience in project leadership in an international organization.
• Advanced GCP understanding.
• Substantial knowledge in Novo Nordisk procedures and processes or equivalent.
• Substantial experience in global end cross-cultural collaboration.
• Ability to build and maintain solid international networks.
• Participation in cross-functional groups incl. international cross functional groups to ensure share better practices on and continuous improvement of processes and procedures globally across project skill and area borders.

The department  

You will join the growing Data Management & Centralized Data Review team anchored in Clinical Data Operations and Insights (Development) with 400+ employees – across Denmark, India, Spain and North America, delivering to the wide Novo Nordisk Development pipeline. You will be part of a larger program organization with cross-functional team members, all working closely together towards our shared vision of democratizing our clinical data.  

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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.  

Contact details   

For further information, please contact Arnab Sengupta, Vice President, Data Management & Centralized Data Review - Clinical Data Operations & Insights (CDOI) at bseg@novonordisk.com 
  

Deadline  
May 5th, 2024. We will process applications as we receive them, so please apply as soon as you can.

There is no requirement to append a cover letter with your application. However, we would appreciate if you could incorporate a brief statement in your resume or CV detailing your motivation for applying. In the interest of promoting an efficient and equitable recruitment process, we kindly request you to exclude any photographs from your CV.

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.