Senior Clinical Operations Manager

About the role

PSI, a privately owned full-service Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry, is looking for a Senior Clinical Operations Manager to join its team in Seoul, South Korea. The role leads and develops the Clinical Operations team in South Korea, helps establish the operational presence in the country and covers both operational and strategic management. The position is office-based or hybrid in Seoul.

Key responsibilities

• Directly manage assigned clinical operations employees in the Seoul office
• Allocate resources to projects, resolve resource conflicts and monitor workload and utilization
• Oversee staff performance, conduct appraisals and foster professional development
• Deliver team training and mentorship, track training compliance and oversee planning, delivery and reporting of field training, including supervised monitoring visits
• Implement quality control, take part in risk review meetings and CAPA investigations, and develop quality systems and documents
• Prepare for and take part in site and systems audits and regulatory inspections
• Attend project review meetings with local project teams and manage crises and conflicts at project and trial site level
• Take part in feasibility assessments, site identification and site selection
• May support business development tasks such as client meetings, trade fairs, key medical events and networking with medical communities and opinion leaders

Required profile

• PharmD or a university degree in Life Sciences or a related field (mandatory)
• Extensive clinical operations management experience, preferably in a CRO or pharmaceutical company
• Strong knowledge of clinical research processes, GCP standards and Korean regulatory requirements
• Substantial experience in personnel management, recruitment, resource allocation and budget oversight
• Fluency in English and Korean

Required skills

• Advanced proficiency in Microsoft Office
• Leadership, communication and interpersonal skills
• Ability to prioritize under pressure and strong analytical and problem-solving skills