Clinical Study Project Manager

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.

The Clinical Research Project Manager oversees the operation of domestic and international clinical research. The manager is responsible for project management and communication with stakeholders while strictly adhering to relevant clinical and regulatory standards. Through this, the manager professionally manages the progress and quality of clinical trials to achieve key business objectives such as obtaining approvals and publishing research.

Responsibilities:

• Project management: Milestones, timelines, budget oversight
• CRO/Vendor selection, qualification, and oversight
• Site selection and communication
• Support development of clinical study protocol
• Contract execution and investigator payments
• IRB/DRB submissions and correspondence
• Study monitoring and quality assurance activities
• Data management including CRF development query management
• TMF and essential document maintenance
• Review clinical study report
• SOP development and compliance

Qualifications: 

• Bachelor’s degree or higher in Medicine, Pharmacy, Nursing, Biotechnology, or Health-related fields
• Minimum 3 years of experience as CRA/PM in pharmaceutical/medical device companies/CROs
• Understanding of domestic and international standards and regulations (KGCP, ICH-GCP, ISO 14155)

Preferred:

• Experience with global/multinational clinical studies
• Experience with clinical studies for drug approval
• Experience working at software as medical device (SaMD) manufacturers

Competencies:

• Strategic thinking based on business mindset
• Document writing and comprehension skills in both Korean and English
• Development of clinical study strategy considering product approval
• Analyzing and problem-solving skills
• Stakeholder management based on clear communication
• To build evidence-based logic through scientific thinking
• Adjusting priorities and effectively managing multiple tasks in a rapidly changing environment
• Ability to thoroughly review and document details
• Compliance and ethical awareness

Benefits:

• Flexible working conditions including work-from-home (2 days per week) 
• Company-supported daily lunch and snacks
• Annual comprehensive health check-up
• 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)
  • Please highlight your motivation for applying to Mediwhale, your interest in the position, and your strengths related to the job
  • Please submit one copy of your resume in both Korean and English.
• Interviews: Each interview is expected to take approximately 30 to 50 minutes