Clinical Trial Associate

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 healthcare 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 USO NN Clinical Development (CDO) 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 CDO 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 CDO.
• Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials improvement/innovation projects for CDO 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 CDO and Novo Nordisk (e.g., across CDO, 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;
• 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.
• Demonstrates 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.
• This position is located in Plainsboro, NJ and required to work onsite 5 days per week.

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.

Pay

The base compensation range for this position is $70K to $123K. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Benefits

• Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
• Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance.