Clintec is actively recruiting for a Medical Monitor to join our expanding global company in South Korea. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
The Medical Monitor will have responsibilities to ensure the safety of subjects participating in Clinical Trials. The Medical Monitor will be expected to take appropriate actions as are delegated to ensure the timely and quality performance of clinical trials, collection of data and completion of Study Reports for assigned projects.
Responsibilities of the Medical Monitor:
· Providing Medical Leadership to the monitoring staff in the region
· Developing and maintaining expertise in the compounds under development and their related fields
· Monitoring the safety of subjects participating in the Clinical Trials
· Selection of Clinical Investigators
· Handling Serious Adverse Event Reports in accordance with the SOPs
· Ensuring timely distribution of IND reports to investigators and EC
· Review and agreement of study budgets with the sites
· Review of the site monitoring reports for safety
· Supporting the CRAs in ensuring that sites conform to GCP and SOPs
· Participating in internal study team meetings
· To participate in the training of the department staff
· Practical experience as a Physician within a hospital environment
· Medical Doctor Degree
· Clinical Trials monitoring experience
· Knowledge of Clinical Trial Regulations in the countries of the Region
· Knowledge of Clinical Trial methodology and design
· Thorough understanding of the protocol, ICH-GCP, ICF and SOPs
· Excellent communication skills and the ability to work both independently and in the team
· Fluency in English and Korean (both written and spoken)
· Willingness and ability to be home or office based in South Korea
· Good computer skills
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.