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Clinical Trial Associate - Site Management

Employer
Novo Nordisk
Location
Plainsboro, NJ
Start date
Nov 28, 2023

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Discipline
Clinical, Clinical Research, Clinical Trials
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

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

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 cross-functional 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 trials, document management and management of clinical trial management systems and archiving systems.

 

Relationships

Reports to a Manager (or above) within NACO.

Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials improvement/innovation projects for NACO 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 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 internal cross functional partners.

 

Essential Functions

  • Executes all relevant services/tasks in support of the planning and quality delivery of clinical trials in line with established targets and metrics including communication of updates
  • Responsible and accountable for tasks, processes and deliverables from trial start up through closure, including but not limited to:
  • Management of clinical trial documents, including but not limited to document receipt, distribution, uploading, indexing, archiving and initial quality review of the eTMF in preparation of, support to, and follow-up of audits and inspections
  • Monitoring of the Investigator Portal for, and Central IRB/REB submission of, SUSARs for assigned clinical trials, including distribution of SUSARs to clinical trial sites
  • Maintenance of systems, e.g., CTMS, eTMF and set up of study email/mailboxes
  • Identification of problems in relation to tasks and key deliverables and mitigate accordingly with guidance from the Trial team
  • Demonstration of technical proficiency within responsibility areas, staying updated with new practices, systems and technologies while building knowledge of emerging trends and advances within area
  • Contribute to Trial Core Team and other relevant teams and ensure transparency in communication and implementation of escalation pathway
  •  

    Physical Requirements

    0-10% overnight travel required; May be required to work company holidays and weekends.

     

    Qualifications

  • A Bachelor’s degree is required (science-related discipline preferred), relevant Novo Nordisk experience may be substituted for degree, when appropriate
  • Clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting preferred; relevant Novo Nordisk experience will apply where appropriate             
  • 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 and clinical trial systems) and adaptability to new systems. Working knowledge of electronic trial master files and clinical trial systems and portals preferred
  • Excellent communications skills (verbal, written, presentation) in English
  • Demonstrated collaborative and stakeholder management skills
  • Strong attention to detail and planning/organizing skills required
  •  

    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
    Telephone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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