Medical Affairs Specialist
About the Company
As a global medical device company originating from Japan, we pursue reliable quality and technology to contribute to healthcare in more than 160 countries and regions around the globe. We promise to walk alongside healthcare professionals to continue to make great contribution to society, now and into the future.
Summary of the Role
The Medical Affairs Specialist works as clinical research associate and serves as a strategic link between Terumo and our Clinical Research Partners.
Key Functions / Responsibilities
Serve as the primary liaison between Terumo and Investigators and his/her site management team. Associate has to manage the whole process of Scientific Research Activities from request intake to closure. The responsibilities will include (not limited to):
Adherence to Protocols: Ensure that all study site activities comply with the established research protocols and guidelines relevant to the study.
Site Readiness Verification: Confirm that the site is equipped to conduct the study, including appropriate facilities, staff qualifications, and ethical approvals.
Local Regulatory & Ethics Confirmation: Confirm that local ethical considerations are met before initiating the study, i.e., product is approved by regulators, and the proposed investigator has ethics committee approval before TC (Terumo Corporate) initiates any funding.
Communication with TC: Maintain communication with TC to inform it of site-specific issues and progress.
Liaison with Study Sites: Coordinate and finalize clinical study agreements with the study sites and arrange execution of such agreements.
Monitoring and Reporting: Monitor site activities, ensuring compliance with the study protocol and promptly reporting any deviations or issues.
Training for Site Staff: Facilitate basic training for all site personnel to ensure they understand the study’s objectives, procedures, and ethical obligations.
Stakeholder Coordination: Liaison with local healthcare providers and community leaders to foster support for the study and ensure transparency.
Final Site Closure: Ensure administrative steps for proper site closure upon study completion, including resolution of outstanding issues and submitting required reports to local stakeholders.
Financial Administration: Support all agreements in a timely manner, ensuring proper invoices and pay outs to centres through TC.
Scientific Reporting: Ensure final completed study and results from investigator are received by TC and disseminated through publications.
Education & Experience
Bachelors’ degree with minimum 5 years of experience in clinical research
Handling investigator initiative trials in Korea, review protocol, and conducted investigator meetings
Preferably someone who has experience working in pharmaceutical, biotechnology and medical device industries are welcomed to apply
Knowledge and understanding in the applicable area
Good verbal & written English communication skill
Excellent communication and interpersonal skills.
Strong organizational and administrative skills.
Advanced level of IT with Microsoft office skills
Fluent in English and local national language (written and spoken)
Proactive team player with a strong drive to create a positive work environment and bring the best result
Ability to work collaboratively in a team environment.
Expertise level of adaptability/ Autonomy/Communication/Scientific and medical knowledge
Ability to manage required travel on a regular basis
Note to External Recruitment Agencies:
Terumo does not recognize candidate submissions from any recruitment agencies and will not be responsible for payment of any recruitment fees due to the hiring of candidates whose resumes were submitted to Terumo employees or offices without the recruiting team's acknowledgement.