CRM/CRA

About us:

Mediwhale is a pioneering AI healthcare startup focusing on predicting cardiovascular, renal, and metabolic disease (CVRM) risks using retinal biomarkers. The eye is the only organ where blood vessels are directly visible without invasive procedures, which is our key to unlocking unprecedented insights into human health.

• Clinical trial planning and execution: Manages the planning, preparation, and execution of clinical trials related to artificial intelligence medical devices through communication with investigators. This may include protocol development, establishment of patient recruitment plans, and data extraction plans for retrospective data.
• Ethics/regulatory compliance and oversight: Ensures that the clinical trial process complies with the regulatory standards of the country and international standards. This includes public IRB submissions, legal advisory, ethical review and IRB submissions, as well as data management and patient safety.
• Data management and analysis: Responsible for the management and analysis of collected clinical data, including ensuring accuracy, consistency, and reliability of the data.
• Site monitoring: Regularly visits clinical trial sites to monitor trial progress and seeks solutions if problems arise.
• Report writing and submission: Compiles clinical trial results and observed data to prepare reports and shares/report them to collaborators. This includes reporting to the CMO, and submission to regulatory agencies, research institutions, etc., through internal RA/QA.
• Project management, communication, and collaboration: Manages schedules, budgets, and resources for various projects related to clinical trials. Also maintains smooth communication and collaboration with clinical trial teams, investigators, medical professionals, regulatory agencies, etc.

Qualifications:

• Written and verbal communication skills including good command of English language.
• Preference for candidates with FDA and US clinical trial experience.
• Preference for candidates with experience in Software as a Medical Device (SaMD).
• 3+ years of experience as an in-house Clinical Research Associate (CRA) or in a dedicated team.
• Bachelor’s Degree in a scientific discipline or healthcare.
• Basic knowledge of, and ability to apply, relevant clinical research regulatory requirements (e.g., GCP, ICH guidelines).

Benefits:

• Flexible working conditions including work-from-home (2 days per week)
• Company supported daily lunch and snacks
• Annual comprehensive health check-up
• Support for congratulatory or condolence expenses
• Medical expense support (covered by group insurance)
• Additional leaves including vaccine leave, birthday leave, and condolence leave, in addition to statutory annual leave
• Support for work-related books and job-related training

Application Process:

• Process: Document screening – 1st interview – 2nd interview – Final Acceptance
  • Tasks may be assigned according to the role, and the interview process may be subject to change.
• Application documents: Free format (including resume)
• Interviews: Each interview is expected to take approximately 30 to 60 minutes.
  • Some interviews may be conducted in English or through video call.