Clinical Trial Manager

Responsibilities

• Independently execute complex Phase I–IV clinical studies across multiple geographic regions, ensuring compliance with GCP, SOPs, FDA/EU regulations, and ICH guidelines.
• Provide day-to-day oversight of CROs and third-party vendors, managing performance, timelines, and budgets.
• Support studies involving radiopharmaceutical and imaging components, including coordination of radiation-related activities and logistics.
• Lead study management activities such as site identification, feasibility, protocol review, and document coordination (ICFs, IRBs, CRFs).
• Manage clinical supply forecasting and accountability, specifically for time-sensitive radiopharmaceutical manufacturing and distribution.
• Escalate significant study risks and operational issues to leadership and develop effective mitigation plans.
• Maintain strong working relationships with investigators, study coordinators, and institutional review boards.

Requirements

• Bachelor's degree or higher in Life Sciences, Pharmacy, Nursing, or a related discipline.
• 6–12 years of relevant clinical trial experience.
• At least 3 years of on-site monitoring experience as a Clinical Research Associate (CRA).
• Proven experience supporting radiopharmaceutical and/or imaging-based clinical studies.
• Thorough knowledge of GCP/ICH, clinical trial design, and global regulatory processes.
• Business-level fluency in spoken and written English.
• Ability to travel approximately 15% for investigator meetings.

Preferred Qualifications

• Master's degree in a relevant scientific field.
• Experience working with global study teams and international CROs.
• Familiarity with radiation safety, imaging operations, or radiopharmaceutical supply chains.
• Experience supporting early-phase oncology studies in Korea and knowledge of local regulatory/IRB requirements.
• Strong project management, negotiation, and multi-disciplinary team leadership skills.

About the Company

SK biopharmaceuticals is a global pharmaceutical company dedicated to developing innovative medicines to improve human health. We focus on advancing clinical development programs through rigorous research and global collaboration.