Develop and implement strategic plans for conducting clinical trials globally, with a focus on gaining approval in highly regulated markets.
Ensure all clinical trials are designed, conducted, and reported in compliance with international standards, including FDA (U.S.), PMDA (Japan), and ISO 14155.
Liaise with regulatory bodies and ensure that all necessary approvals are obtained for conducting clinical trials.
Select and manage relationships with clinical trial sites, including contract negotiations and performance monitoring.
Work closely with ethical committees to ensure all clinical trial activities are carried out with the highest ethical standards.
Oversee the preparation of clinical trial protocols, informed consent forms, and other essential documents.
Manage the clinical trials budget, ensuring resources are allocated efficiently and effectively.
Supervise the clinical trials team, providing guidance and support to ensure project milestones are met.
Analyze and interpret clinical trial data, preparing reports for regulatory submissions.
Stay abreast of industry trends, regulatory changes, and advancements in clinical trial methodologies.
Qualification & Experience
Advanced degree in life sciences, medical sciences, or a related field.
Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role.
Proven track record of successful clinical trial management in highly regulated markets such as the U.S. and Japan.