- 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.
- 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.
Principal CDR Specialist - Søborg, Danmark - Novo Nordisk A/S
Beskrivelse
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:
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.