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Associate Director, Clinical Operations/Country Manager

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

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 141

Description

  • Lead the Clinical Operations Department, including clinical trial management and clinical monitoring activities.
  • Ensure clinical trial operations are delivered on time, within budget, and in compliance with ICH-GCP, Federal regulations, SOPs, FDA, and internal policies.
  • Contribute to the development and revision of clinical SOPs and department guidelines.
  • Manage CRA and other clinical project resources, including interviewing, selecting, and training team members.
  • Coordinate employees and contract Clinical Operations staff, including site assignments, monitoring report review, and calendar oversight.
  • Resolve employee and contractor performance issues, including contract termination when needed.
  • Represent Clinical Operations on company-wide project teams and collaborate with executive management on department development and business planning.
  • Support clinical operations and project team meetings by preparing agendas and minutes.
  • Provide input on proposals, budgets, contracts, and bid defense meetings.
  • Serve as the primary interface with client representatives and internal functional teams to ensure timely clinical trial initiation and completion.

Requirements

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

Interested in this position?

Apply directly on the company website

Apply Now

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