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Site Manager

2 months ago

Merrillville, United States Medix™ Full time

Key Responsibilities:

  • Manage day-to-day operations of the clinical research site, including overseeing clinical trial activities, patient recruitment, and ensuring adherence to study protocols and regulatory requirements.
  • Lead and supervise site staff, including hiring, training, and performance management.
  • Collaborate with Principal Investigators, sponsors, and CROs to plan and execute clinical trials according to timelines and budgets.
  • Ensure site compliance with ICH/GCP guidelines, FDA regulations, and other applicable standards.
  • Monitor study progress, review data quality, and resolve issues to ensure timely and accurate data collection.
  • Implement and maintain standard operating procedures (SOPs) for site operations and ensure staff adherence.
  • Coordinate site visits, audits, and inspections by sponsors, IRBs, and regulatory authorities.
  • Manage site budget, resources, and logistics to support efficient trial conduct.
  • Communicate regularly with stakeholders to provide updates on study progress, milestones, and issues.

Required Qualifications:

  • Bachelor’s degree in life sciences, nursing, or a related field; advanced degree preferred.