Job Purpose
Oversee and manage the activities of Contract Research Organizations (CROs) involved in the planning, execution, and reporting of clinical trials in Pacific Rim (mainly China, Japan, and South Korea). Ensure that CROs adhere to project timelines, budgets, and quality standards.
Main Responsibilities, Activities, Duties, and Tasks
61 Essential Activities, Duties, Tasks and Responsibilities Project Management
o Develop and implement project plans, including timelines and milestones.
o Manage the timeline and budget for assigned clinical trials.
o Perform local CRO selection process as necessary.
o Manage and oversee the performance of CROs, ensuring they meet project deliverables, timelines, and quality standards.
o Coordinate with internal teams and external CROs to ensure seamless project execution.
o Monitor trial progress and take corrective actions as needed to ensure timely completion of clinical trials.
o Maintain open and effective communication with key stakeholders, including CROs, investigators, ethics committees, and regulatory bodies as necessary.
o Ensure adherence to Good Clinical Practice (GCP) and all applicable local and international regulations.
o Conduct regular co-monitoring or independent site visits to maintain compliance and quality of the clinical trials.
o Assist in audit activities when an audit is called for the clinical trials.
o Identify and assess potential risks to project success and develop mitigation strategies.
o Implement risk management plans to minimize the impact of identified risks.
Trial Planning and Design
o Develop and review clinical trial protocols, case report forms (CRFs), and other essential documents.
Ensure alignment with corporate strategic goals and regulatory guidelines.
Other
o Monitoring policy trends related to clinical trials/GCP in China, Japan and South Korea.
o Manage the investigator-initiated studies in the above countries according to SOP and local policy.
o Other activities assigned.
61 Secondary Activities, Duties, Tasks and Responsibilities
o Provide clinical trial expertise to support other medical functions (regulatory, drug safety, medical affairs & scientific information) as needed
Supervisory Responsibilities
61 Not Applicable
Education
61 Bachelor’s degree in a life science, healthcare, or related field; advanced degree (Master’s or PhD) preferred
Professional Experience, Knowledge & Technical Skills
61 Minimum of 5 years of experience in clinical research, preferably in the pharmaceutical or biotechnology industry
61 Proven experience in managing Phase III registration trials.
61 Familiarity with clinical trial regulations and guidelines in China, preferably also in Japan and South Korea.
61 Strong project management, team coordination, and cross-cultural communication skills.
61 Ability to work effectively in a multitasking environment, with attention to detail and problem- solving capabilities.
61 Proficiency in English and at least one local language (Chinese, Japanese, or Korean).
Core Relationships
61 Contract Research Organizations
61 Investigators
61 Regulatory authorities, including NMPA (China), MHLW (Japan), and MFDS (South Korea)
61 Internal teams, including Clinical Research, Regulatory Affairs, Quality Management, and Medical Affairs
Work Environment
61 Ability to travel within China, Japan, and South Korea as required.
61 Capability to work in cross-cultural teams, understanding and respecting cultural differences.