Clinical Trial Specialist

Job Summary:

The Specialist of Clinical Trials will support and manage 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 significant experience in clinical trial management, a deep understanding of regulatory requirements in highly regulated markets, and the ability to work collaboratively with clinical trial sites and ethical committees.

Key Responsibilities:

• Assist in developing and implementing 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.
• Collaborate with regulatory bodies to ensure that all necessary approvals are obtained for conducting clinical trials.
• Support the selection and management of 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.
• Assist in the preparation of clinical trial protocols, informed consent forms, and other essential documents.
• Help manage the clinical trials budget, ensuring resources are allocated efficiently and effectively.
• Provide assistance to the clinical trials team, offering guidance and support to meet project milestones.
• Analyze and interpret clinical trial data, assisting in the preparation of 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 5 years of experience in clinical trial management.
• Proven experience in clinical trials within 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 interpersonal and communication skills.
• Ability to work effectively in a fast-paced and changing environment.
• Proficient in clinical trial software and databases.