Senior Clinical Operations Manager

Company Description

PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. Many of our colleagues have been with us for over 15 years, contributing to our long-standing traditions and history. Our expansion into Asia Pacific region continues this legacy, and we seek team members who will grow with us for the long term.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

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.

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.

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. 

Additional Information

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.