Multiple Positions Available
About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the Food & Drug Administration (FDA) to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?
Takes ownership to deliver upon near-term NACO goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects for the department (subset) of NACO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations. Contributes to a continually changing environment, supporting a future focused approach, leveraging competencies, tools and technology. Maintains responsibility for quality, performance, regulatory compliance and patient safety related to managing assigned clinical trial sites, document handling and trial product handling. Supports off-site monitoring in collaboration with Field Management.
Reports to a Manager (or above) within NACO. Manages mutually beneficial relationships with external partners relevant to the design and implementation of clinical trials improvement/innovation projects for NACO and Novo Nordisk (e.g. clinical trial site staff, clinical research vendors). Manages relationships positively with multiple internal stakeholders relevant to the design and implementation of clinical trials improvement/innovation projects for NACO and Novo Nordisk (e.g., across NACO, CMR, International Operations (IO), HQ R&D and Commercial). Provides excellent customer service and builds strong working relationships with investigative sites and internal cross-functional partners.
- Delivers all relevant services/tasks in support of the planning and execution of quality driven clinical trials in line with established targets and including communication of updates
- Ensures proactive risk identification and mitigation planning for assigned clinical trial sites
- Drives recruitment/retention follow up with clinical trial sites to track and support enrolment strategies
- Provides support to, prepare for and follow-up on audits and inspections
- Shares information, collaborate and provide relevant input and guidance to other areas within NACO, CMR and global partners
- Demonstrates technical proficiency within responsible areas, stay up to date on new practices and build knowledge of emerging trends and advances within area
- Contributes actively to Trial Core Team and other relevant teams
Approximately 10-20% business travel required. May on occasion be required to work and/or travel on weekends and/or company holidays.
- A Bachelor’s degree (science-related discipline preferred); or, a Registered Nurse (RN) degree is required
- Site monitoring experience an asset
- A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required. A minimum of 3 years of experience in the planning and conduct of Good Clinical Practice (GCP) clinical trials, some of more recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical, biotechnology, CRO, and/or healthcare setting
- Demonstrated understanding of medical terminology and International Conference on Harmonisation (ICH)-GCP principles and the application of those principles to trial planning and conduct of clinical trials
- Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
- Excellent communications skills (verbal, written, presentation) in English
- Demonstrated collaborative and stakeholder management skills
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.