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Associate Director, Clinical Operations/Country Manager

44 minutes ago
South Korea
Full-time
Lead
Operations Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 107

Description

  • Provide leadership to the Clinical Operations Department, including Clinical Trial Management and Clinical Monitoring.
  • Ensure clinical trial operations are delivered on time, with high quality, and cost-effectively in compliance with ICH-GCP, FDA, federal regulations, SOPs, and other applicable requirements.
  • Contribute to the development and revision of Clinical SOPs and department guidelines.
  • Ensure adequate CRA and other clinical project resources, including interviewing and selecting CRAs for studies.
  • Coordinate employees and contract Clinical Operations team members, including site assignments, monitoring report review, and calendar oversight.
  • Address employee and contract CRA performance issues, including contract termination when necessary.
  • Represent Clinical Operations on company-wide project teams and cross-functional initiatives.
  • Support Clinical Operations and Project Team meetings by preparing agendas and minutes.
  • Produce periodic reports and contribute input to proposals, budgets, contracts, and bid defense meetings.
  • Hire, train, and help develop Clinical Operations employees, including department job descriptions.
  • Serve as the primary interface with client representatives and internal departments to support timely trial initiation and completion.
  • Coordinate study-specific training and other requirements for internal and external staff.
  • Manage full-service, large-scale, complex clinical projects.

Requirements

  • Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience.
  • At least 10 years of experience in clinical research.
  • Extensive clinical and line management experience, or proven competencies for the position.
  • Excellent communication skills.
  • Strong organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
  • Excellent interpersonal skills to effectively interface with others.
  • Experience monitoring in oncology and complex therapeutic areas is preferred.
  • Based in South Korea.

Interested in this position?

Apply directly on the company website

Apply Now

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