Clinical Trial Manager
2 months ago
Job Summary:
The Manager of Clinical Trials will lead and oversee all clinical trial activities for our medical device portfolio, ensuring compliance with international regulatory standards for markets including the U.S. and Japan. The role requires extensive experience in clinical trial management, a deep understanding of regulatory requirements in highly regulated markets, and the ability to work effectively with clinical trial sites and ethical committees.
Key Responsibilities:
- 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.
Qualifications:
- 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.
- Strong understanding of regulatory requirements, ethical considerations, and quality standards relevant to medical device clinical trials.
- Experience working with clinical trial sites and ethical committees.
- Excellent communication, negotiation, and project management skills.
- Fluent in English, with proficiency in other languages (such as Japanese) being a plus.
Skills:
- Strategic thinking and analytical skills.
- Strong leadership and team management capabilities.
- Excellent interpersonal and communication skills.
- Ability to work in a fast-paced and changing environment.
- Proficient in clinical trial software and databases.
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