Senior Clinical Trial Associate

About the Department

The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference? 

The Position

We are seeking a highly organized and detail-oriented Senior Clinical Trial Associate to assist with the execution of clinical trials.  This is a unique opportunity to work in a growing Clinical Operations Department that manages multiple early-stage clinical programs based on an innovative RNAi technology platform. 

Relationships

Reports to: 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 reports, tracking of site visits, and assisting with contract & ICF review
• Assist the Clinical Project Manager in external vendor management. This could include participating in the selection process, providing ongoing oversight of selected vendors, negotiating change orders, and escalation of issues
• 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. This includes the ability to provide input into the protocol and study plans
• Manage internal study meetings inclusive of setting agendas, recording and distributing minutes
• 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 electronic Trial Master File within established guidelines, maintain up-to-date documentation for all study sites globally
• Assist in the review of data (protocol deviations, data cleaning, etc.)
• Preparing training materials and supporting trainings
• Support invoice and budget activities, including contract execution

Physical Requirements

10-20% overnight travel required.

Qualifications

• Bachelor’s degree with a preferred focus on a life science or healthcare related field             
• 5+ years of clinical trial experience, with 3+ years of industry experience supporting clinical studies at a CRO or pharmaceutical company
• 1+ years of experience working directly for a sponsor
• 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.