Senior Clinical Trial Manager
1주일전에
We are seeking a seasoned Senior Clinical Trial Manager to lead the execution of complex clinical trials across various therapeutic areas. This role requires strategic planning, leadership, and operational expertise to ensure timely completion within budgets.
Job Description:
Leadership and Management:
This position involves providing guidance and oversight to clinical trial teams, managing resources, and leading organizational change initiatives. The ideal candidate will have excellent leadership presence and strong interpersonal skills.
Clinical Trial Execution:
The selected individual will develop, implement, and ensure completion of clinical trials within set timelines and budgets. They must possess advanced knowledge of study management best practices and tools.
Risk Mitigation and Problem Solving:
This role demands strategic analysis, risk mitigation strategies, and problem-solving skills to address regulatory and investigator interaction issues. The candidate should be able to anticipate obstacles and find effective solutions.
Communication and Documentation:
The successful candidate will keep stakeholders informed on project status and issues, using tools to track and communicate program status. They must also contribute to study-related documentation and SOPs.
Requirements:
Bachelor's degree or higher in life sciences or a related field with 15+ years of relevant experience, or Master's degree with 10+ years of relevant experience.
A minimum of 10 years cross-functional study management or related leadership experience, including managing study management or project teams.
Proven ability to manage clinical studies within designated program budgets and timelines.
Expertise in authoring clinical study and regulatory documentation and SOPs.
Skills and Qualifications:
Expert knowledge of one or more disease or therapeutic areas (Oncology, Virology, and/or Inflammation).
Complete knowledge of full cycle study management.
Advanced knowledge of study management best practices and tools.
Thorough knowledge of FDA, EMA, ICH guidelines, and GCP.
Strong financial acumen for clinical trial budgets.
Proven ability to author clinical study and regulatory documentation.
Strong leadership presence with the ability to lead without authority.
Strong interpersonal skills and understanding of team dynamics.
Excellent verbal and written communication skills in English and Korean.
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