Internship, Clinical Operations

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

Clinical Development is the department within Novartis Gene Therapies that is responsible for the planning, execution, and oversight of studies conducted in humans (clinical studies). The purpose of these studies is to determine the safety and efficacy of new treatments for disease. The ultimate goal of evaluating new treatments for diseases is for potential approved by the Food and Drug Administration and other regulatory authorities OR to determine at an early time point that the new treatment is not effective or have unacceptable risks.

Novartis Gene Therapies is seeking a Clinical Operations Intern who has a passion for clinical research. The Clinical Operations Intern will be responsible to learn and to collaborate with Novartis Gene Therapies staff within various functional groups such as Clinical Documentation, Clinical Site Monitoring, Study Management, Medical Writing, Process Excellence, and Data Management. The position will provide exposure to ICH E6(R2) Good Clinical Practices principles and their application in clinical trials.

Responsibilities

• Attend cross-functional clinical project team meetings and other departmental meetings, as needed.
• Create, upload, and quality check essential documents being uploaded to the Trial Master File (TMF).
• Assist in ensuring that essential documents remain current in the TMF during clinical trial conduct.
• Shadow clinical site monitoring staff in selected activities such as visit report writing, remote monitoring activities, and analysis of clinical site monitoring oversight data.
• May be assigned to shadow Global Patient Safety staff.
• Preparation and delivery of a final presentation to Clinical Operations staff prior to concluding internship.
• May be assigned a project within any of the Clinical Operations functional departments.

Qualifications

• Enrollment in a 4-year degree program in a biological or allied health field with a 3.0 GPA required; Students enrolled in a clinical research academic program highly preferred.
• Exhibits strong time management and organizational skills.
• Ability to build and maintain positive relationships with peers and management staff.
• Proficiency in Microsoft Office applications required, e.g., Word, Excel, PowerPoint, etc.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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