- Lead the development of strategy for digitalization of risk-based data review, ensuring alignment with industry best practices and regulatory requirements.
- Evaluate and implement cutting-edge technologies, including AI/ML-driven tools, to enhance efficiency and accuracy in data review processes.
- Work with Data Now, Data Core etc. to develop clinical data flow model and clinical data review model.
- Collaborate with cross-functional teams to design and implement innovative data review models that leverage advanced analytics and automation.
- Assess vendors and service providers for their capabilities in supporting centralized data review functions, including negotiation of contacts and service level agreements, if needed.
- Drive transformation of data review processes, ensuring compliance, efficiency, speed, and quality.
- Develop complex visualizations to facilitate data analysis and interpretation.
- Stay abreast of emerging trends and advancements in data review solutions.
- Mentor and coach junior team members, fostering their professional development and enhancing team competencies.
- Minimum requirements often PhD with 8+ years relevant experience or Masters in Computer Science, Engineering, Health Science or related field; with 12 + years relevant developing data review tools and digitalizing data review strategies, preferably in the healthcare or life sciences industry
- Profound experience of working with clinical systems used in drug development.
- Proven expertise in AI/ML technologies and their application in data review processes.
- Solid knowledge in the field of relational database systems.
- Proficiency in data visualization tools and techniques.
- Strong understanding of clinical data management principles and regulatory requirements.
- Excellent leadership and communication skills, with the ability to collaborate effectively with cross-functional teams in local and global, cross- cultural settings.
- In-depth knowledge of the full value chain in clinical development.
- Profound project management experience and experience in project leadership in an international organization.
- Substantial knowledge of GCP, Novo Nordisk procedures and processes or equivalent.
Principal DM Operations - Søborg, Danmark - Novo Nordisk A/S
Beskrivelse
Are you passionate about leveraging cutting-edge technologies to drive innovation in data review processes? Do you have a strong background in AI/ML technologies and their application in the healthcare or life sciences industry? If so, we have an exciting opportunity for you to join our growing Data Insights team at Novo Nordisk. Apply today and be part of a team that is revolutionizing clinical data management.
The position
The Principal DM Operations & Insights 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 DM Operations & Insights Specialist, you will have the opportunity to:
Qualifications
To excel in this role, you should possess the following qualifications:
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.