Senior Clinical Operations Manager

Job Description

We're on the lookout for a highly skilled and experienced Senior Clinical Operations Manager to join our team in Seoul, South Korea. As a key member of PSI Korea, you will lead and develop our Clinical Operations team in South Korea, help to establish our operational presence in the country, and enjoy all aspects of operational & strategic management.

Qualifications

The following qualifications are essential for this critical role:

• PharmD or university degree in Life Sciences or related field is mandatory.
• Extensive experience in clinical operations management, preferably in a CRO or pharmaceutical company, is required.
• Comprehensive knowledge of clinical research processes, GCP standards, and local regulatory requirements in Korea is crucial.
• Substantial experience in personnel management, recruitment, resource allocation, and budget oversight is necessary.
• Exceptional leadership, communication, and interpersonal skills are imperative.
• Fluency in English and Korean is non-negotiable.
• Advanced proficiency in Microsoft Office applications is required.
• Demonstrated ability to prioritize effectively in high-pressure situations is essential.
• Strong analytical and problem-solving skills are vital for success in this position.

The successful candidate will be expected to uphold the highest standards of professionalism and contribute significantly to the company's growth and success in the Korean market.

Office-based/Hybrid in Seoul

You will:

• Direct line manages assigned clinical operations employees in Seoul office.
• Manage resource allocation to projects and resolution of resourcing conflicts, resource workload and utilization.
• Oversee staff performance to ensure efficiency and productivity.
• Conduct performance appraisal and foster professional development of departmental staff.
• Team training and mentorship, training compliance tracking.
• Oversee planning, conduct and reporting of field training. Perform supervised monitoring visits.
• Implement quality control, participate in Risk Review Meetings and CAPA investigation meetings.
• Develop and implement quality systems, including quality systems documents.
• Prepare for and participate in site and systems audits/ regulatory inspections.
• Attend project review meetings with the local project teams. Manage crisis and resolves conflicts on project and trial site levels.
• Participate in feasibility assessment, project-specific site identification and selection.
• May support with Business Development tasks such as client meetings, trade fairs, key medical events and networking with medical communities and opinion leaders.

How are we different?

PSI is privately owned by the very people who founded the company more than 30 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.

Growth Opportunities

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.