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?
The Position
Takes ownership to deliver upon near-term North American Clinical Operations (NACO) goals, including successful delivery of studies within the clinical trial portfolio. Maintains responsibility for quality, performance, regulatory compliance and patient safety related to managing assigned clinical trial sites, document handling and trial product handling. Has responsibility for all monitoring activities (on-site and off-site) of assigned clinical trial sites according to the Monitoring Plans, ICH and GCP guidelines.
Relationships
Reports to a Manager (or above) within NACO. Manages mutually beneficial relationships with external partners relevant to the design and implementation of clinical trials and 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 and improvement/innovation projects for NACO & Novo Nordisk (e.g., across NACO, CMR, International Operations (IO), HQ R&D, & Commercial). Provides excellent customer service and builds strong working relationships with investigative sites and internal cross-functional 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
- Verifies Serious Adverse Events (SAE) reporting according to trial specification and ICH-GCP guidelines
- 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 enrollment strategies
- Attends on-site audits, prepares for and follow-up on audits and inspections, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Clinical Site Lead (CSL) and /or Trial Manager (TM)
- Shares information, collaborates and provides relevant input and guidance to other areas within NACO, CMR, and Global partners
- Demonstrates technical proficiency within responsible areas, staying up-to-date on new practices and builds knowledge of emerging trends and advances within area
- 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
- Contributes actively to relevant teams as assigned
- 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
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. Novo Nordisk requires all new hires, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.
Qualifications
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A qualified candidate must have a Bachelor’s degree* (science related discipline preferred) and meet one of the following:
- Has a minimum of 2 years of on-site monitoring experience required
- Or has 4 years’ experience as a site coordinator and/or working experience in GCP-related clinical research including a sufficient combination of relevant education and on-the-job training deemed appropriate to fulfill the requirements of the position
- Alternatively, a Registered Nurse with a minimum of 3 years of on-site monitoring experience is acceptable, in lieu of a Bachelor’s degree
A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required
Requires understanding of medical and scientific concepts in order to effectively interpret protocol requirements, support site and effectively conduct monitoring activities. CRA role is complex and requires the ability to balance multiple competing priorities, stakeholders, timelines and mitigate risks
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, MS Project, MS PowerPoint)
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.
Source: Indeed.com
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