Clinical Research Study Manager

2 weeks ago


Newark, New Jersey, United States Vitalief Full time
Job Title: Clinical Research Study Manager

Vitalief is seeking a highly skilled Clinical Research Study Manager to join our team. As a Clinical Research Study Manager, you will be responsible for managing clinical research studies, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to achieve project goals.

Key Responsibilities:
  • Manage clinical research studies from initiation to close-out, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
  • Collaborate with cross-functional teams, including research staff, physicians, and other stakeholders to achieve project goals.
  • Develop and implement study protocols, case report forms, and other study-related documents.
  • Ensure accurate and timely data collection, entry, and reporting.
  • Conduct quality assurance audits to ensure data integrity and compliance with regulatory requirements.
Requirements:
  • Bachelor's degree in a life science or related field.
  • 5+ years of experience in clinical research, with a focus on study management.
  • Experience with clinical trials management systems (CTMS) and electronic data capture (EDC) systems.
  • Strong knowledge of regulatory requirements, including GCP, ICH, and FDA regulations.
  • Excellent communication and project management skills.
What We Offer:
  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.


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