Instagram
youtube
Facebook

Clinical Trial Associate - Site Management

0-2 years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills:

Job Description: Clinical Trial Manager

Location: Plainsboro, United States
Job Category: Clinical Development

About the Department

The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is a diverse and collaborative team dedicated to healthcare provider interactions, regulatory strategy development, medical education, and clinical data collection. Our goal is to enhance patient care through innovation, ensuring that new and existing products improve lives worldwide.

The Position

The Clinical Trial Manager is responsible for supporting the successful planning, execution, and completion of clinical trials within Novo Nordisk’s North America Clinical Development (NACD) portfolio. The role involves working cross-functionally to drive continuous improvement, ensuring regulatory compliance, maintaining quality, and leveraging emerging tools and technology.

Key Responsibilities

1. Clinical Trial Execution & Management

  • Oversee the planning and delivery of clinical trials according to established targets and metrics.
  • Ensure transparency in communication and proper implementation of the escalation pathway for trial-related issues.
  • Contribute to Trial Core Teams and cross-functional groups.

2. Trial Documentation & Compliance

  • Manage clinical trial documents, including:
    • Receipt, distribution, uploading, indexing, archiving, and initial quality review within the electronic Trial Master File (eTMF).
    • Preparation, support, and follow-up for audits and inspections.
  • Monitor the Investigator Portal and submit Safety Updates (SUSARs) to clinical trial sites and Central IRB/REB.
  • Maintain and update clinical trial management systems (CTMS, eTMF) and study email/mailboxes.

3. Stakeholder Collaboration & Problem Solving

  • Identify and mitigate challenges related to trial tasks and key deliverables.
  • Build strong relationships with internal and external stakeholders, including clinical trial site staff and research vendors.
  • Demonstrate adaptability by staying updated with new technologies and clinical trial practices.

Physical Requirements

  • 0-10% overnight travel may be required.
  • May be required to work on company holidays and weekends as needed.

Qualifications

Education:

  • Bachelor’s degree required (preferably in a science-related discipline).
  • Relevant Novo Nordisk experience may be substituted for the degree when appropriate.

Experience & Skills:

  • Clinical trial experience in pharmaceutical, biotechnology, CRO, or healthcare settings preferred.
  • Understanding of medical terminology and ICH-GCP principles in trial planning and execution.
  • Proficiency in MS Office, electronic trial master files (eTMF), and clinical trial systems preferred.
  • Strong communication, stakeholder management, attention to detail, and organizational skills.

Equal Opportunity Employer

Novo Nordisk is committed to diversity, equity, and inclusion in hiring. We provide equal employment opportunities regardless of race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other legally protected characteristic.

Accommodation Requests

If you need assistance or accommodation to apply, please call 1-855-411-5290 (for accommodation requests only).