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Clinical Site & Start-up Associate

Employer
Novo Nordisk
Location
Plainsboro, NJ
Start date
Feb 21, 2024

Job Details

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.

Company

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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Company info
Website
Phone
617-612-6200
Location
75 Hayden Avenue
Lexington
MA
02421
US

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