Principal CDR Specialist
3 weeks ago
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.
-
Principal Pharmacovigilance Specialist
5 days ago
Søborg, Gladsaxe Municipality, Denmark Novo Nordisk AS - VTx Full timeAre you ready to assume a key coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and co-operating with many different stakeholders, at all levels of the organisation? If you find challenges like this...
-
Principal Pharmacovigilance Specialist
6 days ago
Søborg, Denmark Novo Nordisk AS - VTx Full timeAre you ready to assume a key coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and co-operating with many different stakeholders, at all levels of the organisation? If you find challenges like...
-
Principal Pharmacovigilance Specialist
2 weeks ago
Søborg, Denmark Novo Nordisk AS Full timeAre you ready to assume a key coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and co-operating with many different stakeholders, at all levels of the organisation? If you find challenges like...
-
Principal Project Manager
3 weeks ago
Søborg, Denmark Novo Nordisk Full timeThe position As a Principal Project Manager for CMO and Expansion Projects, you will be responsible of impactful projects that are global, cross-functional, and of strategic priority. You will work closely together with specialists and project managers both within and outside the company. Your primary task will include: Leading tech transfer projects...
-
Principal Project Manager
1 week ago
Søborg, Denmark Novo Nordisk AS - VTx Full timeAre you a talented project manager and would you like to work with talented colleagues? Then this is your moment, as we are looking for senior project managers to join our new department “CMO and Expansion Projects”. So, do you want to lead strategic expansion projects with high impact for Novo Nordisk, and do you enjoy delivering in close cooperation...
-
Principal Project Manager
3 weeks ago
Søborg, Denmark Novo Nordisk AS Full timeAre you a talented project manager and would you like to work with talented colleagues? Then this is your moment, as we are looking for senior project managers to join our new department “CMO and Expansion Projects”. So, do you want to lead strategic expansion projects with high impact for Novo Nordisk, and do you enjoy delivering in close cooperation...
-
Principal Pharmacovigilance Specialist
2 weeks ago
Søborg, Denmark Novo Nordisk Full timeThe position is placed in the QPPV Office in Global Safety. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. In QPPV Office we are around 50 colleagues with different professional background divided into different departments ensuring maintenance...
