Novo Nordisk Plainsboro , NJ 08536
Posted 2 weeks ago
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 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?
The Position
Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ownership to deliver upon near-term North America Clinical Development (NACD) 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) NACD 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.
Relationships
Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials improvement/innovation projects for NACD and Novo Nordisk (e.g., clinical trial site staff, IRBs, clinical research vendors).
Manages relationships with multiple internal stakeholders relevant to the planning and implementation of clinical trials improvement/innovation projects for NACD and Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), HQ R&D and Commercial).
Provides excellent customer service and builds strong working relationships with investigative sites and internal/external partners.
Essential Functions
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 and tracks site activation and start-up activities with clinical trial sites to support trial start-up strategies
Provides system and device expertise to train and support clinical trial sites
Ensures ongoing collection and review of relevant documentation e.g., related to protocol amendments, site staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance with NN SOPs, relevant regulatory requirements and ICH and GCP guidelines
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 NACD, CMR and global partners
Demonstrates technical proficiency within responsible areas, stays up to date on new practices systems, and technologies while building knowledge of emerging trends and advances within area
Contributes actively to Trial Core Team and other relevant teams
Physical Requirements
0-10% overnight travel required; May be required to work company holidays and weekends.
Qualifications
A Bachelor's degree (science-related discipline preferred) or a Registered Nurse (RN) degree is required
A minimum of 3 years of experience in the planning and conduct of 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 required
A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required
Relevant Novo Nordisk experience will apply where appropriate
Site activation and site management/monitoring experience is an asset
Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
Demonstrated computer skills (MS Office, clinical trial systems) and adaptability to new systems
Excellent communications skills (verbal, written, presentation) in English
Demonstrated collaborative and stakeholder management skills
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.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
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.
Novo Nordisk