다음과 같이 국내 유명 바이오 제약회사에서 'RPT Clinical Trial Manager' 담당자를 찾습니다.
* Job Title : RPT Clinical Trial Manager
* Position : 선임급
* Experience : 임상시험 관련 경력 6~12년
* Location : 본사 (경기)
[RESPONSIBILITIES]
1. Study Management & Leadership
- Lead and manage global clinical trials involving radiopharmaceutical and/or imaging-based studies
- Oversee study timelines, budget, quality, enrollment, and operational execution
- Lead study start-up, feasibility assessment, site selection, and study management activities
- Ensure compliance with protocol requirements, GCP, SAE reporting, and regulatory processes
- Collaborate with investigators, study sites, CROs, and global cross-functional teams
- Identify, escalate, and mitigate study risks, operational issues, and quality concerns
2. CRO, 3rd Party Vendor Management and Oversight / Budget
- Lead CRO and vendor selection, oversight, and performance management
- Manage vendors supporting radiopharmaceutical manufacturing, imaging services, and logistics
- Monitor study timelines, enrollment, operational metrics, and vendor deliverables
- Support clinical supply planning, forecasting, and study budget management
- Review study invoices, change orders, and financial forecasts
- Coordinate investigator meetings, study trainings, and vendor-related activities
[QUALIFICATIONS]
- 전공 : 생명과학, 약학, 간호학 등 관련 전공 학사 이상 (석사, 박사 우대)
- 경력 : 임상시험 관련 경력 6~12년
* 필수사항
- 6-12 years' relevant clinical trial experience
- Thorough knowledge of GCP/ICH, clinical trial design, regulatory processes, and global clinical development process
- Experience supporting radiopharmaceutical and/or imaging-based clinical studies is required
- Excellent written and verbal English communication skills are required
- Ability to multitask
- Adapts to change
- Maintain composure under pressure
- Ability to follow verbal or written instructions and use of effective verbal communications
- Grasps information quickly
- Examine and observe details
- Proficient communication, influencing, and negotiating skills
- Strong project management skills and demonstrated ability to meet timelines
- Proven ability to work independently and to lead a multi-disciplinary trial team(s)
- Strong interpersonal, problem-solving, negotiation, and conflict resolution
- Demonstrated ability to effectively communicate and collaborate across global teams in a matrix environment
- Approximate 15% travel for investigator meetings
* 우대사항
- Familiarity with radiation safety, imaging operations, or radiopharmaceutical supply considerations is an asset
- Experience working with global study teams and international CROs is strongly preferred
- Experience supporting early phase oncology studies in Korea and knowledge of local regulatory and IRB requirements is preferred