Description

About the Role

As a Clinical Project Manager, you will take full ownership of local and international clinical projects, ensuring they run smoothly, on time, and to the highest quality standards. You will lead cross-functional teams, be the main connection point for sponsors, and play a key role in delivering meaningful clinical outcomes.

This position is perfect for someone who enjoys autonomy, leadership, and seeing the direct impact of their work across multiple studies.

What You Will Do

Lead & Inspire

• Drive all clinical project activities, ensuring timelines, budgets, and quality benchmarks are achieved.
• Lead dedicated study teams and foster a supportive, high-performance environment.
• Mentor new team members and contribute to internal capability building.

Be the Study Owner

• Plan and oversee the entire project lifecycle - from feasibility to close-out.
• Organize kick-off meetings, sponsor updates, and investigator meetings.
• Anticipate risks and proactively deliver solutions before they affect timelines.

Strengthen Site & Monitoring Excellence

• Oversee feasibility assessments, site selection, study start-up, and enrolment performance.
• Ensure CRAs are fully aligned on study expectations and monitoring standards.
• Review visit reports, resolve site issues, and conduct/co-monitor visits when needed.

Drive Quality & Documentation

• Keep the Trial Master File always inspection-ready.
• Ensure accurate, timely documentation across the full study cycle.
• Support continuous improvement and ensure high-quality deliverables.

Manage Budgets & Vendors with Confidence

• Track study budgets, forecasts, and resource allocation.
• Collaborate closely with Finance and Vendor Management on billing, contracts, and vendor oversight.
• Ensure vendors deliver on time and to agreed standards.

Partner with Cross-Functional Teams

• Work with Regulatory, Start-up, Data Management, and other key functions to move studies forward efficiently.
• Manage IMP/IP/Medical Device supply, expiry, and study materials.

What You Bring

• A degree in a scientific/health-related field.
• Minimum 2 years of experience as a Clinical Research Associate (CRA).
• Solid understanding of ICH-GCP, ISO14155, and monitoring methodologies.
• Strong leadership, communication, and problem-solving skills.
• Ability to work independently while collaborating closely with a global team.
• Fluent in English (Korean fluency is an asset but not required).

What We Offer

• A competitive salary and comprehensive benefits package.
• Performance bonuses and recognition.
• A supportive environment that encourages learning, development, and career mobility.
• The opportunity to work on a diverse range of global studies with a growing international CRO.
• A culture built on science, quality, integrity, and innovation.

Who We Are

OPIS is an international, privately owned CRO with 25+ years of experience in managing Phase I-IV, non-interventional, and medical device studies worldwide. We combine scientific expertise with innovative technology to deliver high-quality clinical research solutions. With global locations and a growing presence in Asia, OPIS offers integrated services across clinical operations, medical writing, data management, pharmacovigilance, QA, and more.

Why Join OPIS?

At OPIS, you're not just managing studies, you're influencing the future of clinical research. You'll work in a collaborative, science-driven environment where your expertise is valued, your ideas matter, and your professional growth is a priority. With over 25 years of global experience and an expanding presence in Asia, OPIS offers stability, innovation, and genuine career progression.

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