Clinical Trial Associate

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 Associate Director or 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

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.