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Clinical Trial Associate

Employer
Novo Nordisk
Location
Lexington, MA
Start date
Aug 3, 2024

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

About the Department

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

We are seeking a highly organized and detail oriented Clinical Trial Associate (CTA) to assist with the execution of clinical trials.

 

Relationships

This position reports to the Director, Clinical Operations.

 

Essential Functions

  • Support the clinical development team in the overall management of studies, including planning, execution and closeout of outsourced clinical trials
  • Assist the Clinical Project Manager in site management activities. This could include review of monitoring report, tracking of site visits, and communication with monitors and sites
  • Work closely with clinical project managers to assist with preparation of all external and internal documentation for assigned trials to ensure it’s completed in accordance with GCP regulatory requirements and consistent with the study protocol
  • Assist in the creation of and distribution of study materials and communications to KOLs, CROs and other external vendors
  • Organize and prepare study files related to study tracking and reporting and submit them to the Trial Master File within established guidelines, maintain up-to-date documentation for all study sites globally
  • Assist the project team with planning, preparation and possible on-site support of investigator’s meetings
  • Support invoice and budget activities

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    Physical Requirements

    10-20% overnight travel required.

     

    Qualifications

  • Bachelor’s degree required, preferably in a science or healthcare related discipline
  • A minimum of 3 years of experience supporting clinical studies at a pharmaceutical, biotechnology company or a CRO preferred
  • Working knowledge of ICH GCP regulations and clinical protocols
  • Strong interpersonal, organizational and multi-tasking skills
  • Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency

    •  

    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
    United States
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