Clinical Trial Associate - Site Management

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 North America Clinical Development (NACD) 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 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. 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 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, 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 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.