Medical Affairs - Officer

Job Description:

We are seeking a highly skilled professional with a medical background to coordinate and manage multi-center clinical trials, ensuring compliance with ICH-GCP and Hong Kong/Mainland regulations. This role requires regular travel between Hong Kong and Mainland China to oversee trial execution and stakeholder collaboration.

Responsibilities:

• Trial Management: Oversee end-to-end clinical trial processes, including protocol design, site selection, ethics submissions, and data monitoring.

• Stakeholder Coordination: Act as the primary liaison between cross-border sites, CROs, and regulatory bodies to ensure adherence to timelines, quality, and compliance.

• On-Site Oversight: Conduct monitoring visits, risk assessments, and mitigation strategies to maintain trial integrity.

• Regulatory Documentation: Prepare and review essential trial documents, including Investigator's Manual (IM) and progress reports aligned with regulatory standards.

• Data Analysis & Reporting: Support data analysis and regulatory filings and perform other duties as assigned to advance COCHE’s mission.

General Qualification:

• Education: Master’s degree or higher in Medicine, Pharmacy, Public Health, or a related field (QS100 qualification preferred).

• Experience:
  Minimum 5+ years in Medical Affairs, preferably with medical device trials.
  Strong knowledge of ICH-GCP, with global/multi-regional trial experience highly desirable.

• Technical Skills:
  Proficiency in EDC/CTMS systems and clinical trial software.
  Fluency in English and Chinese (written and spoken).

• Soft Skills:
  Self-motivated, results-driven, and able to thrive in a fast-paced environment.
  Willingness to travel (~25% of the time).

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