Location: HK

Reports To: Senior Regional Medical Affairs Manager

Job status: Full-time

Job Responsibilities

• Implement and monitor clinical studies to ensure the compliance with local regulations, ICH/GCP and CFDA GCP guidelines.
• Ensure effective project plan and management including start-up process, clinical study master files, site selection, vendor proposal and review, site reports preparation etc.
• Support and monitor operational aspects of CRO and other project-related vendors
• Ensure the clinical data are complete and accurate, and all study documentation is filed
• Support Budget and Contract Coordination
• Assist Medical Affairs functions
• Execute clinical programs and educational activities for both internal and external parties
• Conduct clinical trainings related to assigned disease/ therapeutics area for both internal and external parties
• Provide scientific supports to cross-functional teams
• Collaborate with different teams to solve any clinical issues in a timely manner
• Provide medical writing if necessary
• Ad-hoc projects assigned as required
  
  
  

Education and Experience

• Bachelor's degree in healthcare-related sciences, pharmacy, or nursing would be ideal
• Minimum of 2 years in clinical research from a pharmaceutical or a medical device company or a CRO would be preferred
• Good knowledge of ICH/ GCP, local regulations, research process and cancer treatments
• Strong communicational, interpersonal, negotiation, presentation, project and time management skills
• Able to handle multiple projects concurrently and work in a fast-paced environment
• Capable to learn, interpret and provide scientific information and data in relation to the assigned disease/ therapeutics area
• Proficient with Microsoft Office products including: Word, Excel, and PowerPoint
• Fluency in English and Mandarin is a must
• Up to 50% travel required
  
  

Please state your current and expected salary in your CV.

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