Address
Form of workAbout 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 and delivery of quality Clinical Research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and site management activities.
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 an Operations Lead (or above) within NACD.
Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials and improvement/innovation projects for NACD and Novo Nordisk (e.g., clinical trial site staff, Clinical Research vendors).
Manages relationships with multiple internal stakeholders relevant to the planning and implementation of clinical trials and improvement/innovation projects for NACD & Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), and HQ R&D).
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 implementation of quality driven clinical trials, in line with established targets and strategies
- Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials
- Verifies safety reporting and the proper handling, monitoring and storage of trial product according to trial specifications, NN SOPs, ICH-GCP guidelines, and relevant regulatory requirements
- Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring Plan and other associated trial documents
- Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops therapeutic area knowledge sufficient to support role and responsibilities
- Drives recruitment and retention strategies to support clinical trial sites to meet country enrollment and retention targets
- Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA)
- Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners
- Demonstrates technical proficiency within responsible areas, staying up-to-date on new practices, systems, and technologies while building knowledge of emerging trends and advances within area
Physical Requirements
50-75% overnight travel required; Driver must maintain a valid driver’s license. Must be in good standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records.; May be required to work company holidays and weekends. The incumbent must reside close to Los Angeles or San Diego, California.
Qualifications
- A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting is required
- A minimum of 2 years of on-site monitoring experience is required, however monitoring experience may be waived if relevant Novo Nordisk experience is demonstrated in GCP-related Clinical Research
- Bachelor’s degree required* (science related discipline preferred):
- *Alternatively, a Registered Nurse with a minimum of 3 years of on-site monitoring experience is acceptable, in lieu of a Bachelor’s degree
- Requires understanding of medical and scientific concepts in order to effectively interpret protocol requirements, support sites and effectively conduct monitoring activities. The CRA role is complex and requires the ability to balance multiple competing priorities, stakeholders, timelines and mitigate risks
- Demonstrates understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
- Demonstrates proficiency with computer skills (MS Office, MS Project, MS PowerPoint)
- Excellent communications skills (verbal, written, presentation) in English
- Demonstrates 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.
