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Clinical Trial Operations Manager

2 months ago

Bristol, Maine, United States Medpace Full time
Job Summary

Medpace is a leading contract research organization (CRO) specializing in clinical trial management. Our team is dedicated to delivering high-quality services to the biotechnology, pharmaceutical, and medical device industries. We are seeking an experienced Clinical Trial Operations Manager to join our Oncology team.

Key Responsibilities
  • Project Management: Oversee the day-to-day operations of clinical trials, ensuring timely completion of project deliverables and adherence to ICH/GCP and regulatory requirements.
  • Sponsor Liaison: Serve as the primary point of contact for operational project-specific issues and study deliverables, maintaining open communication with sponsors and stakeholders.
  • Team Leadership: Lead a team of clinical research associates (CRAs) and project coordinators, providing guidance and oversight to ensure successful project execution.
  • Protocol Management: Maintain in-depth knowledge of study protocols, therapeutic areas, and indications, ensuring accurate and compliant execution.
  • Vendor Management: Manage relationships with study vendors, ensuring timely delivery of services and adherence to contractual agreements.
  • Quality Assurance: Oversee site quality and monitoring deliverables, ensuring compliance with regulatory requirements and Medpace's quality standards.
Requirements
  • Education: Bachelor's degree or higher in a health or life science-related field.
  • Experience: At least two years of clinical trial management experience in the Asia Pacific region, with a strong understanding of oncology and related therapeutic areas.
  • Skills: Excellent communication and leadership skills, with the ability to work effectively in a global environment.